Product Code: DQY FDA class 2 21 CFR 870.1250

Catheter, Percutaneous

Cardiovascular

The Percutaneous Catheter is a cardiovascular device designed to be inserted through the skin into a blood vessel using a needle-based percutaneous technique, enabling minimally invasive vascular access for diagnostic or therapeutic interventions. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQY and it is regulated under 21 CFR 870.1250 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

881

FEI Numbers

271

Registration Numbers

272

Unique Applicants

332

Years Active

Basic Information

Product Code: DQY
Device Class: FDA class 2
Regulation Number: 870.1250
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 881 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250972	Primum Hydrophilic Guiding Catheter	Jun 29, 2025	Substantially Equivalent	PendraCare
K250828	CPS Locator 3D Plus Delivery Catheter	Jun 27, 2025	Substantially Equivalent	CenterPoint Systems LLC
K243184	SAT CenterFlow Molding Balloon Catheter (IN20-00313)	Jun 25, 2025	Substantially Equivalent	Strait Access Technologies Holdings
K250492	FlexiGo 3D Delivery Catheter	Jun 18, 2025	Substantially Equivalent	CenterPoint Systems LLC
K250219	Dorado PTA Balloon Dilatation Catheter	Jun 17, 2025	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K250410	GORE® Tri-Lobe Balloon Catheter	Jun 02, 2025	Substantially Equivalent	W. L. Gore & Associates, Inc.
K243757	Shockwave CS Guide Catheter	May 02, 2025	Substantially Equivalent	Shockwave Medical, Inc.
K251014	APRO 45 Catheter	May 01, 2025	Substantially Equivalent	Alembic, LLC
K250962	APRO 55 Intermediate Catheter	Apr 29, 2025	Substantially Equivalent	Alembic, LLC
K250426	Amulet Steerable Delivery Sheath	Apr 25, 2025	Substantially Equivalent	Abbott Medical
K242337	FlowGuide (FG60F); GuidionShort (GS60F)	Apr 17, 2025	Substantially Equivalent	IMDS Operations B.V.
K243691	LiquID .051 LP Guide Catheter Extension	Apr 04, 2025	Substantially Equivalent	Seigla Medical, Inc.
K250558	SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)	Mar 27, 2025	Substantially Equivalent	Medtronic, Inc.
K243436	Seclusion Catheter	Feb 28, 2025	Substantially Equivalent	Basis Medical
K242873	Ventrax Delivery System	Jan 15, 2025	Substantially Equivalent	Merit Medical Systems, Inc.
K242588	COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)	Jan 07, 2025	Substantially Equivalent	OrbusNeich Medical (Shenzhen) Co., Ltd.
K243224	MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)	Dec 31, 2024	Substantially Equivalent	Abbott Medical
K242644	SENDERO MAX Delivery Catheter	Dec 20, 2024	Substantially Equivalent	Okami Medical, Inc.
K240885	Shadow Catheter	Dec 19, 2024	Substantially Equivalent	Simpson Interventions, Inc.
K243180	SSPC NXT Delivery Catheter	Dec 04, 2024	Substantially Equivalent	CenterPoint Systems LLC
K242276	CrossFAST Integrated Microcatheter Guide Extension System (CFM55)	Sep 30, 2024	Substantially Equivalent	Vantis Vascular, Inc.
K240787	Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)	Sep 12, 2024	Substantially Equivalent	Biotronik, Inc.
K241611	ShapeIT (SI014135)	Sep 03, 2024	Substantially Equivalent	IMDS Operations B.V.
K241538	TriClip Steerable Guide Catheter	Aug 26, 2024	Substantially Equivalent	Abbott Medical
K233637	Cordis BRITECROSS Support Catheter	Jun 28, 2024	Substantially Equivalent	Cordis US Corp.
K241158	ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3	Jun 25, 2024	Substantially Equivalent	Asahi Intecc Co., Ltd.
K241177	React 71 Catheter	May 28, 2024	Substantially Equivalent	Micro Therapeutics lnc. d/b/a ev3 Neurovascular
K234115	APRO 55 Catheter	Mar 15, 2024	Substantially Equivalent	Alembic, LLC
K240384	SENDERO Microcatheter	Mar 08, 2024	Substantially Equivalent	Okami Medical, Inc.
K233350	SINC Support Catheter	Feb 08, 2024	Substantially Equivalent	Reflow Medical, Inc.
K240018	WATCHMAN TruSteer Access System (M635TU90050)	Feb 01, 2024	Substantially Equivalent	Boston Scientific Corporation
K231608	Teleport XT Microcatheter	Jan 07, 2024	Substantially Equivalent	OrbusNeich Medical (Shenzhen) Co., Ltd.
K233858	TriSalus TriGuideTM Guiding Catheter	Dec 27, 2023	Substantially Equivalent	TriSalus Life Sciences
K231600	SENDERO Microcatheter	Nov 17, 2023	Substantially Equivalent	Okami Medical, Inc.
K231629	091 Balloon Guide Catheter	Oct 31, 2023	Substantially Equivalent	EOSolutions, Corp.
K232437	Paragon 8F Balloon Guide Catheter	Oct 13, 2023	Substantially Equivalent	Wallaby Medical
K232690	Amulet Steerable Delivery Sheath	Sep 29, 2023	Substantially Equivalent	Abbott Medical
K232647	Microcatheter	Sep 29, 2023	Substantially Equivalent	Surmodics. Inc.
K231246	Ventrax Delivery System (VTR851)	Aug 30, 2023	Substantially Equivalent	Merit Medical Systems, Inc.
K232190	6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter	Aug 22, 2023	Substantially Equivalent	Medtronic Vascular
K223633	Rubicon Control Support Catheter (H749394323506A1)	Aug 08, 2023	Substantially Equivalent	Boston Scientific Corporation
K231044	R2P Navicross	Jul 27, 2023	Substantially Equivalent	Terumo Medical Corporation
K223728	Micro Rx	Jul 13, 2023	Substantially Equivalent	IMDS Operations B.V.
K230156	5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter	Jun 30, 2023	Substantially Equivalent	Medtronic Vascular
K231311	CPS Direct Universal slittable outer guide catheter (DS2C029)	Jun 02, 2023	Substantially Equivalent	Abbott Medical
K231176	Stingray LP Catheter	May 25, 2023	Substantially Equivalent	Boston Scientific
K222023	RayFlow	Apr 06, 2023	Substantially Equivalent	Hexacath
K230363	CPS Locator 3D Delivery Catheter	Mar 09, 2023	Substantially Equivalent	CenterPoint Systems LLC
K222603	6F Wallaby Long Sheath	Mar 02, 2023	Substantially Equivalent	Wallaby Medical Inc
K222115	ISAAC Neurovascular Navigation Catheter	Jan 10, 2023	Substantially Equivalent	MicroVention, Inc.
K223178	SelectSite C304 Deflectable Catheter System, C315 Delivery System	Nov 08, 2022	Substantially Equivalent	Medtronic
K222873	Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system	Nov 07, 2022	Substantially Equivalent	Medtronic
K213466	Houdini Cross Support Catheter	Oct 20, 2022	Substantially Equivalent	Cruzar Medsystems Inc
K221886	Sublime Microcatheter	Oct 14, 2022	Substantially Equivalent	Surmodics Inc.
K214024	SOFIA 88 Catheter	Sep 12, 2022	Substantially Equivalent	MicroVention, Inc.
K220647	GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)	Aug 18, 2022	Substantially Equivalent	Vascular Solutions LLC
K220331	091 Balloon Guide Catheter	Jul 29, 2022	Substantially Equivalent	InNeuroCo Inc.
K222037	Selectra Lead Implantation System	Jul 19, 2022	Substantially Equivalent	Biotronik, Inc.
K221846	Artix Ballon Guiding Sheath	Jul 11, 2022	Substantially Equivalent	Inari Medical
K221750	CPS AIM Universal II Slittable Inner Catheter	Jun 30, 2022	Substantially Equivalent	Abbott Medical
K220632	Boss Crossing Support Catheter	Jun 02, 2022	Substantially Equivalent	Marvao Medical Devices Ltd
K220716	Spartan SC 069	May 05, 2022	Substantially Equivalent	Spartan Micro, Inc.
K220691	LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension	May 05, 2022	Substantially Equivalent	Seigla Medical, Inc.
K212588	Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter	May 04, 2022	Substantially Equivalent	C.R. Bard, Inc
K214107	XO CROSS CORONARY Support Catheter	Apr 11, 2022	Substantially Equivalent	Transit Scientific, LLC
K220340	Amplatzer Steerable Delivery Sheath	Mar 09, 2022	Substantially Equivalent	Abbott Medical
K212211	Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter	Feb 09, 2022	Substantially Equivalent	Vascular Solutions LLC
K214106	QuikPass Catheter	Jan 28, 2022	Substantially Equivalent	Traverse Vascular, Inc.
K210009	Guiding Catheter	Nov 24, 2021	Substantially Equivalent	CenterPoint Systems LLC
K210322	XO Cross Support Catheter	Oct 21, 2021	Substantially Equivalent	Transit Scientific, LLC
K212738	Amplatzer Talisman Delivery Sheath	Sep 27, 2021	Substantially Equivalent	Abbott Medical
K212026	Amplatzer Steerable Delivery Sheath	Sep 27, 2021	Substantially Equivalent	Abbott Medical
K212725	ViperCross Support Catheters	Sep 24, 2021	Substantially Equivalent	Cardiovascular Systems, Inc.
K211240	ViperCross Support Catheters	Aug 26, 2021	Substantially Equivalent	Cardiovascular Systems, Inc.
K212228	WATCHMAN FXD Curve Access System	Aug 13, 2021	Substantially Equivalent	Boston Scientific Corporation
K211990	Rist 071 Radial Access Guide Catheter	Jul 27, 2021	Substantially Equivalent	Micro Therapeutics, Inc., d/b/a ev3 Neurovascular
K201706	KDL Micro catheter	Jul 22, 2021	Substantially Equivalent	Shanghai Kindly Medical Instruments Co., Ltd.
K210431	ReCross	Jul 15, 2021	Substantially Equivalent	IMDS Operations B.V.
K201726	Arterial Catheter	Jul 07, 2021	Substantially Equivalent	Haolang Medical USA Corporation
K210188	coraCross	May 28, 2021	Substantially Equivalent	Reflow Medical
K211251	ViperCath XC Peripheral Exchange Catheter	May 26, 2021	Substantially Equivalent	Cardiovascular Systems, Inc.
K210647	SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter	Apr 30, 2021	Substantially Equivalent	Vascular Solutions LLC
K210601	Plato 17 Microcatheter	Apr 28, 2021	Substantially Equivalent	Scientia Vascular LLC
K210110	Guidion	Mar 31, 2021	Substantially Equivalent	IMDS Operations B.V.
K203521	FineCross M3	Mar 03, 2021	Substantially Equivalent	Ashitaka Factory of Terumo Corporation
K203275	Recon Support Catheter	Mar 01, 2021	Substantially Equivalent	C.R. Bard, Inc.
K210230	Phenom Catheters	Feb 25, 2021	Substantially Equivalent	Micro Therapeutics, lnc. d/b/a ev3 Neurovascular
K202610	Ventrax Delivery System	Dec 14, 2020	Substantially Equivalent	Merit Medical Systems, Inc.
K201811	coraForce and coraFlex Support Catheters	Oct 26, 2020	Substantially Equivalent	Reflow Medical, Inc.
K193474	Selectra 3D Outer Guiding Catheters	Oct 16, 2020	Substantially Equivalent	BIOTRONIK, Inc
K202252	ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),	Sep 08, 2020	Substantially Equivalent	Asahi Intecc Co., Ltd.
K200324	NHancer Rx	Aug 06, 2020	Substantially Equivalent	IMDS Operations B.V.
K192712	Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter	Aug 03, 2020	Substantially Equivalent	Medtronic Inc
K193607	BOBBY Balloon Guide Catheter	Jul 21, 2020	Substantially Equivalent	MicroVention, Inc.
K193119	Twin-Pass Dual Access Catheter	Jun 29, 2020	Substantially Equivalent	Vascular Solutions LLC
K201271	Benchmark BMX96 Access System	Jun 11, 2020	Substantially Equivalent	Penumbra, Inc.
K200721	Agilis HisPro Steerable Catheter With Electrodes	Jun 03, 2020	Substantially Equivalent	Abbott (St. Jude Medical)
K200317	Support Catheter	May 14, 2020	Substantially Equivalent	QXMedical, LLC
K193420	XO Cross Support Catheter	May 06, 2020	Substantially Equivalent	Transit Scientific
K192558	Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter	Apr 06, 2020	Substantially Equivalent	MIVI Neurovascular
K193322	NovaCross CTO Microcatheter	Apr 02, 2020	Substantially Equivalent	Nitiloop Ltd.
K200094	speX LP Support Catheter	Mar 18, 2020	Substantially Equivalent	Reflow Medical
K193596	Wingman 14, Wingman 14C, Wingman 18, Wingman 35	Feb 20, 2020	Substantially Equivalent	Reflow Medical
K193012	speX Support Catheter	Feb 19, 2020	Substantially Equivalent	ReFlow Medical
K191229	TrapIt	Jan 21, 2020	Substantially Equivalent	IMDS Operations B.V.
K191717	Route 92 Medical Sheath System	Jan 13, 2020	Substantially Equivalent	Route 92 Medical Inc.
K192774	BioCardia 8F Morph DNA Deflectable Guide Catheter	Jan 07, 2020	Substantially Equivalent	BioCardia
K192135	VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)	Dec 24, 2019	Substantially Equivalent	MicroVention, Inc.
K191551	RIST Cath Radial Access Long Sheath	Dec 23, 2019	Substantially Equivalent	RIST Neurovascular, Inc.
K190833	AXS Vecta Aspiration Catheter	Dec 15, 2019	Substantially Equivalent	Stryker Neurovascular
K191163	Lumax Guiding Catheter	Dec 12, 2019	Substantially Equivalent	Cook Incorporated
K193034	AXS Infinity LS Plus Long Sheath	Nov 29, 2019	Substantially Equivalent	Stryker Neurovascular
K192782	ASAHI CROSSWALK Peripheral Support Catheter	Nov 29, 2019	Substantially Equivalent	Asahi Intecc Co., Ltd.
K192996	Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool	Nov 21, 2019	Substantially Equivalent	Biotronik, Inc
K192625	PG Pro Microcatheter	Nov 21, 2019	Substantially Equivalent	MicroVention, Inc., A Terumo Group Company
K191237	CERENOVUS Large Bore Catheter	Nov 08, 2019	Substantially Equivalent	Codman & Shurtleff, Inc.
K192525	087 Balloon Guide Catheter System	Oct 31, 2019	Substantially Equivalent	Q'Apel Medical LLC
K192296	Medtronic 6F Taiga Guiding Catheter	Sep 20, 2019	Substantially Equivalent	Medtronic Vascular
K191664	SelectFlex 072 Neurovascular Access System	Aug 30, 2019	Substantially Equivalent	Q'Apel Medical
K191560	Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter	Aug 09, 2019	Substantially Equivalent	Vascular Solutions LLC
K183305	Crossing Support Catheter	Aug 05, 2019	Substantially Equivalent	Tractus Vascular LLC
K182487	CerusEndo Microcatheter	Jul 20, 2019	Substantially Equivalent	Cerus Endovascular, Inc.
K190749	087 Balloon Guide Catheter System	Jul 15, 2019	Substantially Equivalent	Q'Apel
K182829	Scepter Mini Occlusion Balloon Catheter	Jul 10, 2019	Substantially Equivalent	MicroVention Inc.
K190475	Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4	Jun 28, 2019	Substantially Equivalent	CenterPoint Systems
K182844	ASAHI SASUKE	Jun 22, 2019	Substantially Equivalent	Asahi Intecc Co., Ltd.
K182937	Upstream GoBack Crossing Catheter	May 23, 2019	Substantially Equivalent	Upstream Peripheral Technologies, Ltd.
K182602	SOFIA EX Intracranial Support Catheter	May 15, 2019	Substantially Equivalent	Micro Vention Inc.
K190393	Wingman 14C Crossing Catheter	May 09, 2019	Substantially Equivalent	ReFlow Medical, Inc.
K190581	Amplatzer Trevisio Intravascular Delivery System	Apr 05, 2019	Substantially Equivalent	Abbott Medical
K183353	Telescope Guide Extension Catheter	Mar 22, 2019	Substantially Equivalent	Medtronic Inc.
K190431	Route 92 Medical Delivery Catheter	Mar 21, 2019	Substantially Equivalent	Route 92 Medical Inc.
K182918	Ballast 088 Long Sheath	Mar 21, 2019	Substantially Equivalent	Balt USA LLC
K190401	MAMBA and MAMBA Flex Microcatheters	Mar 15, 2019	Substantially Equivalent	Boston Scientific Corporation
K183493	SelectSite C304-HIS Deflectable Catheter System	Mar 15, 2019	Substantially Equivalent	Medtronic Inc.
K183463	AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm	Mar 13, 2019	Substantially Equivalent	Stryker
K182570	Venture 0.014 Catheter	Mar 13, 2019	Substantially Equivalent	Vascular Solutions, LLC
K183000	ViperCath XC Peripheral Exchange Catheter	Dec 29, 2018	Substantially Equivalent	Cardiovascular Systems, Inc.
K182420	ASAHI Corsair Pro XS	Dec 20, 2018	Substantially Equivalent	Asahi Intecc Co., Ltd.
K180797	Xcess Guiding Catheter	Dec 14, 2018	Substantially Equivalent	Curatia Medical Co.
K183265	Selectra Catheters, Selectra Accessory Kit	Dec 13, 2018	Substantially Equivalent	Biotronik, Inc.
K182512	Route 92 Medical Delivery Catheter	Dec 10, 2018	Substantially Equivalent	Route 92 Medical Inc.
K180889	Tractus Crossing Support Catheter	Dec 07, 2018	Substantially Equivalent	Tractus Vascular LLC
K182097	React 71 Catheter	Nov 14, 2018	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K182360	Teleport Microcatheter	Nov 09, 2018	Substantially Equivalent	OrbusNeich Medical Trading Inc.
K180919	GORE Tri-Lumen Catheter	Oct 05, 2018	Substantially Equivalent	W.L. Gore and Associates Inc.
K181563	The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology	Sep 26, 2018	Substantially Equivalent	Access Scientific, LLC
K181000	SelectFlex 072 Neurovascular Access System	Sep 13, 2018	Substantially Equivalent	Q'Apel
K180169	EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length	Aug 08, 2018	Substantially Equivalent	Imperative Care Inc.
K180864	WATCHMAN TruSeal Access System	Jul 20, 2018	Substantially Equivalent	Boston Scientific
K180715	React 68 Catheter	Jul 04, 2018	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K180959	Phenom 27 Catheter	Jun 11, 2018	Substantially Equivalent	Cathera, Inc.
K180201	Route 92 Medical Access System	May 23, 2018	Substantially Equivalent	Route 92 Medical, Inc.
K180986	XableCath Support Catheter Product Family	May 15, 2018	Substantially Equivalent	XableCath, Inc.
K173661	Wingman 35 Crossing Catheter	Apr 18, 2018	Substantially Equivalent	ReFlow Medical, Inc.
K172014	Wedge Microcatheter	Apr 05, 2018	Substantially Equivalent	Micro Vention, Inc.
K180088	TrapLiner catheter	Apr 04, 2018	Substantially Equivalent	Vascular Solutions, Inc.
K173548	Merit Pursue Microcatheter	Mar 30, 2018	Substantially Equivalent	Merit Medical Systems, Inc.
K173799	NaviCross 0.018	Mar 29, 2018	Substantially Equivalent	Terumo Corporation
K173709	Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm	Jan 26, 2018	Substantially Equivalent	InNeuroCo, Inc
K173560	Microcatheter	Jan 12, 2018	Substantially Equivalent	Surmodics, Inc.
K171819	Attain Assist CS Access Catheter	Jan 04, 2018	Substantially Equivalent	Creganna Medical also doing business as Ceganna Tactx Medica
K173662	speX Support Catheter	Dec 20, 2017	Substantially Equivalent	ReFlow Medical, Inc.
K172468	091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm	Dec 06, 2017	Substantially Equivalent	InNeuroCo, Inc
K170914	TXM Support Catheter	Nov 21, 2017	Substantially Equivalent	Texas Medical Technologies, Inc.
K170664	Odyssey Micro Catheter	Nov 09, 2017	Substantially Equivalent	Heraeus Medical Components, LLC
K172090	GuideLiner V3 Catheter	Oct 20, 2017	Substantially Equivalent	Vascular Solutions, Inc.
K171672	065 Zenith, 074 Zenith	Oct 19, 2017	Substantially Equivalent	InNeuroCo, Inc
K172297	NovaCross Microcatheter	Oct 18, 2017	Substantially Equivalent	Nitiloop Ltd.
K171176	M-CATH Microcatheter	Sep 15, 2017	Substantially Equivalent	Acrostak (Schweiz) AG
K170041	XableCath Support Catheter	Sep 07, 2017	Substantially Equivalent	XABLECATH, INC.
K171452	MAMBA and MAMBA FLEX Microcatheters	Aug 21, 2017	Substantially Equivalent	Boston Scientific Corporation
K163259	AXS Offset Delivery Assist Catheter	Jul 28, 2017	Substantially Equivalent	STRYKER NEUROVASCULAR
K171913	Rubicon 14, 18 and 35 Support Catheters	Jul 25, 2017	Substantially Equivalent	Boston Scientific Corporation
K171653	YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up	Jul 03, 2017	Substantially Equivalent	Codman & Shurtleff, Inc.
K171612	ACUITY Pro Lead Delivery System	Jun 30, 2017	Substantially Equivalent	Boston Scientific Corporation
K171146	Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.	Jun 23, 2017	Substantially Equivalent	Arrow International, Inc. (Subsidiary of Telelflex Inc.)
K170996	Wingman 14C Crossing Catheter	Jun 09, 2017	Substantially Equivalent	ReFlow Medical, Inc.
K171335	Venture 038 catheter	Jun 07, 2017	Substantially Equivalent	Vascular Solutions, Inc.
K171268	Reverse 021 Micro Catheter, Reverse 027 Micro Catheter	May 31, 2017	Substantially Equivalent	MicroTherapeutics, Inc. d/b/a ev3 Neurovascular
K163233	MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter	Apr 06, 2017	Substantially Equivalent	MIVI NEUROSCIENCE, INC
K163314	Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter	Mar 23, 2017	Substantially Equivalent	Boston Scientific Corporation
K170403	CenterCross Ultra LV Catheter	Mar 07, 2017	Substantially Equivalent	Roxwood Medical, Inc.
K162565	VIA 17 Microcatheter	Feb 18, 2017	Substantially Equivalent	SEQUENT MEDICAL, INC.
K161901	TrapLiner catheter	Feb 03, 2017	Substantially Equivalent	Vascular Solutions, Inc.
K162467	Twin-Pass Torque	Feb 01, 2017	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K162253	Trapper Exchange Device	Jan 06, 2017	Substantially Equivalent	CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
K162563	YOGA Microcatheter	Jan 05, 2017	Substantially Equivalent	CODMAN & SHURTLEFF, INC.
K163000	AMPLATZER TorqVue 45x45 Delivery Sheath	Dec 23, 2016	Substantially Equivalent	AGA Medical Corporation (Wholly Owned by St. Jude Medical Co
K160561	Boosting Catheter	Nov 02, 2016	Substantially Equivalent	QXMEDICAL, LLC
K161546	R2P SlenGuide	Oct 14, 2016	Substantially Equivalent	ASHITAKA FACTORY OF TERUMO CORPORATION
K161152	Navien Intracranial Support Catheter	Oct 12, 2016	Substantially Equivalent	MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
K162384	TrailBlazer Angled Support Catheter	Sep 22, 2016	Substantially Equivalent	Medtronic Vascular, Inc.(formerly ev3 Inc.)
K162359	Surefire Guiding Catheter	Sep 21, 2016	Substantially Equivalent	Surefire Medical, Inc.
K161262	Super Distal Access (SDA)	Sep 19, 2016	Substantially Equivalent	INNEUROCO, INC
K162228	TorqVue Low Profile Delivery Catheter	Sep 09, 2016	Substantially Equivalent	AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR
K161126	ASAHI Corsair Pro	Aug 25, 2016	Substantially Equivalent	ASAHI INTECC CO., LTD.
K161986	SIDEKICK and USHER Support Catheters	Aug 04, 2016	Substantially Equivalent	BARD PERIPHERAL VASCULAR, INC.
K160848	Wingman 18 Crossing Catheter	Jul 14, 2016	Substantially Equivalent	ReFlow Medical, Inc.
K160448	ARTLINE	Jul 12, 2016	Substantially Equivalent	HEALTH LINE INTERNATIONAL CORPORATION
K160681	CenterCross Ultra Catheter	Jun 17, 2016	Substantially Equivalent	ROXWOOD MEDICAL, INC
K161362	ASAHI Corsair Armet	Jun 14, 2016	Substantially Equivalent	Asahi Intecc Co., Ltd.
K153703	Guiding Catheter	May 12, 2016	Substantially Equivalent	Texas Medical Technologies, Inc.
K160389	NovaCross Microcatheter	Mar 11, 2016	Substantially Equivalent	Nitiloop Ltd.
K152957	MultiCross Catheter	Mar 04, 2016	Substantially Equivalent	ROXWOOD MEDICAL, INC.
K152249	ASAHI Corsair Armet	Mar 04, 2016	Substantially Equivalent	ASAHI INTECC CO., LTD.
K153729	8F FlowGate2 Balloon Guide Catheter	Jan 27, 2016	Substantially Equivalent	CONCENTRIC MEDICAL
K152456	CenterCross Ultra Catheter	Jan 26, 2016	Substantially Equivalent	ROXWOOD MEDICAL, INC.
K152447	ASAHI Caravel	Jan 22, 2016	Substantially Equivalent	ASAHI INTECC CO., LTD.
K152876	LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM	Jan 08, 2016	Substantially Equivalent	TNI Manufacturing, Inc.
K152202	Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm	Dec 14, 2015	Substantially Equivalent	TNI Manufacturing, Inc.
K151396	MIVI Mi-AXUS Guide Catheter	Dec 09, 2015	Substantially Equivalent	MIVI NEUROSCIENCE, INC
K151896	Houdini Catheter	Dec 07, 2015	Substantially Equivalent	Cruzar Medsystems, Inc.
K152401	Stingray LP Catheter	Dec 04, 2015	Substantially Equivalent	BOSTON SCIENTIFIC CORPORATION
K152840	Lantern Delivery Microcatheter	Dec 02, 2015	Substantially Equivalent	PENUMBRA, INC.
K151667	AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm	Nov 13, 2015	Substantially Equivalent	Stryker
K151638	Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter	Nov 13, 2015	Substantially Equivalent	Cathera, Inc.
K151821	ER-REBOA Catheter	Oct 23, 2015	Substantially Equivalent	Pryor Medical Devices, Inc
K150894	VIA 21 Microcatheter	Aug 28, 2015	Substantially Equivalent	SEQUENT MEDICAL, INC
K151981	Turnpike catheter	Aug 13, 2015	Substantially Equivalent	VASCULAR SOLUTION, INC.
K151880	Wingman Crossing Catheter	Aug 07, 2015	Substantially Equivalent	REFLOW MEDICAL
K151409	Selectra Catheters and Selectra Accessory Kit	Aug 07, 2015	Unknown	BIOTRONIK, INC.
K150865	Metacross RX PTA Balloon Dilitation Catheter	Aug 03, 2015	Substantially Equivalent	Kaneka Corporation
K150107	Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter	Jul 29, 2015	Substantially Equivalent	MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR
K151103	ASAHI Corsair Microcatheter	Jun 23, 2015	Substantially Equivalent	ASAHI INTECC CO., LTD.
K151082	MicroCross Catheter	Jun 07, 2015	Substantially Equivalent	ROXWOOD MEDICAL, INC.
K150970	Coda LP Balloon Catheter	May 12, 2015	Substantially Equivalent	COOK INCORPORATED
K143608	NovaCross Microcatheter	May 04, 2015	Substantially Equivalent	Nitiloop Ltd.
K143744	MicroCross Catheter	Apr 14, 2015	Substantially Equivalent	ROXWOOD MEDICAL, INC.
K143459	Silk Road Acccess Catheter	Apr 01, 2015	Substantially Equivalent	SILK ROAD MEDICAL, INC
K150366	SOFIA 6F Catheter	Mar 27, 2015	Substantially Equivalent	MICROVENTION, INC.
K142449	Headway 27 Microcatheter	Mar 26, 2015	Substantially Equivalent	MICRO VENTION, INC.
K141981	ASAHI FUBUKI 043 / ASAHI FUBUKI	Mar 09, 2015	Substantially Equivalent	ASAHI INTECC CO., LTD.
K150201	Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter	Feb 27, 2015	Substantially Equivalent	SPECTRANETICS, INC.
K141354	NAVAJO PTA BALLOON DILATATION CATHETER	Jan 30, 2015	Substantially Equivalent	CURATIVE MEDICAL INC.
K142321	Benchmark Intracranial Access System	Jan 26, 2015	Substantially Equivalent	PENUMBRA, INC.
K143412	ADROIT Guiding Catheter	Jan 14, 2015	Substantially Equivalent	CORDIS CORPORATION
K142239	CPS Direct MediGuide Enabled outer catheter	Dec 18, 2014	Substantially Equivalent	St. Jude Medical
K142235	CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter	Dec 18, 2014	Substantially Equivalent	St. Jude Medical
K141529	ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER	Dec 03, 2014	Substantially Equivalent	ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S
K142065	TURNPIKE CATHETER	Nov 25, 2014	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K140910	CENTERCROSS CATHETER	Nov 19, 2014	Substantially Equivalent	ROXWOOD MEDICAL, INC.
K142565	Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter	Nov 14, 2014	Substantially Equivalent	Stryker Neurovascular
K141649	SPEX SUPPORT CATHETER	Nov 05, 2014	Substantially Equivalent	REFLOW MEDICAL
K142014	SOFIA DISTAL ACCESS CATHETER	Oct 10, 2014	Substantially Equivalent	MICROVENTION, INC.
K141547	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	Sep 30, 2014	Substantially Equivalent	REFLOW MEDICAL
K140557	MIVI 6F GUIDE CATHETER	Sep 18, 2014	Substantially Equivalent	MIVI, LLC
K140080	ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB	Apr 24, 2014	Substantially Equivalent	Codman & Shurtleff, Inc.
K140307	ENVOY GUIDING CATHETER	Apr 21, 2014	Substantially Equivalent	Codman & Shurtleff, Inc.
K132914	ACUITY PRO LEAD DELIVERY SYSTEM	Apr 03, 2014	Substantially Equivalent	BOSTON SCIENTIFIC
K133539	TOTAL ACROSS	Mar 26, 2014	Substantially Equivalent	MEDTRONIC VASCULAR
K140034	SUREFIRE GUIDING CATHETER	Feb 26, 2014	Substantially Equivalent	SUREFIRE MEDICAL, INC.
K133501	LEADLINER CS LEAD DELIVERY SYSTEM	Feb 25, 2014	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K133177	MODIFIED HD GUIDE CATHETER	Feb 25, 2014	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K131592	ENLIGHTN RENAL GUIDE CATHETER	Jan 31, 2014	Substantially Equivalent	ST. JUDE MEDICAL, INC.
K131204	ADVANCE CS CORONARY SINUS INFUSION CATHETER	Jan 29, 2014	Substantially Equivalent	COOK, INC.
K133026	UNBALLOON NON-OCCLUSION MODELING CATHETER	Dec 31, 2013	Substantially Equivalent	LEMAITRE VASCULAR, INC.
K132652	VIA MICROCATHETER, VIA PLUS MICROCATHETER	Dec 20, 2013	Substantially Equivalent	SEQUENT MEDICAL, INC
K131482	SOFIA DISTAL ACCESS CATHETER	Nov 22, 2013	Substantially Equivalent	MICRO VENTION, INC.
K132542	TRANSGATE GUIDE CATHETER	Nov 15, 2013	Substantially Equivalent	STRYKER NEUROVASCULAR
K130649	SILK ROAD ACCESS CATHETER	Nov 01, 2013	Substantially Equivalent	SILK ROAD MEDICAL, INC
K132556	SHEATHLESS EAUCATH CORONARY GUIDE CATHETER	Oct 24, 2013	Substantially Equivalent	ASAHI INTECC CO., LTD.
K132673	5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER	Oct 22, 2013	Substantially Equivalent	MEDTRONIC INC.
K130378	RESPIGUIDE DELIVERY SYSTEM	Oct 17, 2013	Substantially Equivalent	RESPICARDIA
K130858	REVERSE MEDICAL MICROCATHETER	Oct 11, 2013	Substantially Equivalent	REVERSE MEDICAL CORPORATION
K131492	MODIFIED FLOWGATE BALLOON GUIDE CATHETER	Oct 03, 2013	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K130525	OCCLUSION PERFUSION CATHETER	Oct 03, 2013	Substantially Equivalent	ADVANCED CATHETER THERAPIES, INC.
K132659	VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM	Sep 27, 2013	Substantially Equivalent	VOLCANO CORPORATION
K132701	PRIMI SUPPORT CATHETER	Sep 26, 2013	Substantially Equivalent	THERMOPEUTIX INC.
K132420	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	Sep 19, 2013	Substantially Equivalent	REFLOW MEDICAL
K132409	CONCIERGE GUIDING CATHETER	Aug 29, 2013	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K131978	SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL	Aug 23, 2013	Substantially Equivalent	BIOTRONIK, INC.
K130714	PROGIGY SUPPORT CATHETER	Aug 22, 2013	Substantially Equivalent	RADIUS MEDICAL, LLC
K131063	AMPLATZER TORQ VUE LP DELIVERY SYSTEM	Aug 15, 2013	Substantially Equivalent	ST. JUDE MEDICAL
K132197	CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER	Aug 12, 2013	Substantially Equivalent	PENDRACARE INTERNATIONAL, B.V.
K131493	SIDEKICK AND USHER SUPPORT CATHETERS	Aug 02, 2013	Substantially Equivalent	C.R. BARD, INC.
K122917	CODA BALLOON CATHETER	Jun 28, 2013	Substantially Equivalent	COOK, INC.
K130850	PRIMI AND SECONDI SUPPORT CATHETERS	Jun 25, 2013	Substantially Equivalent	THERMOPEUTIX INC.
K131225	ADROIT GUIDING CATHETER	May 29, 2013	Substantially Equivalent	CORDIS CORP., A JOHNSON & JOHNSON CO.
K122826	PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM	Apr 24, 2013	Substantially Equivalent	VOLCANO CORPORATION
K123153	ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT	Apr 09, 2013	Substantially Equivalent	MEDTRONIC IRELAND
K130257	CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER	Mar 20, 2013	Substantially Equivalent	ST. JUDE MEDICAL
K130252	CPS AIM UNIVERSAL SLITTABLE INNER CATHETER	Mar 20, 2013	Substantially Equivalent	ST. JUDE MEDICAL
K123765	GUIDEZILLA GUIDE EXTENSION CATHETER	Mar 19, 2013	Substantially Equivalent	BOSTON SCIENTIFIC
K122940	ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3	Mar 19, 2013	Substantially Equivalent	COOK, INC.
K123311	QXMEDICAL ACCESS & SUPPORT CATHETER	Jan 14, 2013	Substantially Equivalent	QXMEDICAL, LLC
K123324	SELECTRA 7F CATHETERS	Jan 11, 2013	Substantially Equivalent	BIOTRONIK, INC.
K123452	TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM	Jan 03, 2013	Substantially Equivalent	Stryker
K121077	NHANCER	Dec 21, 2012	Substantially Equivalent	IMDS OPERATIONS B.V.
K123531	UNBALLOON NON-OCCLUSIVE MODELING CATHETER	Dec 14, 2012	Substantially Equivalent	LEMAITRE VASCULAR, INC.
K122684	REVERSE MEDICAL MICROCATHETER	Dec 07, 2012	Substantially Equivalent	REVERSE MEDICAL CORPORATION
K121763	MULTICROSS SUPPORT CATHETER	Nov 27, 2012	Substantially Equivalent	ROXWOOD MEDICAL, INC.
K122581	MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254	Nov 21, 2012	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K122772	PENUMBRA DDC CATHETERS	Nov 20, 2012	Substantially Equivalent	PENUMBRA, INC.
K121219	ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER	Sep 25, 2012	Substantially Equivalent	MEDTRONIC INC.
K121859	TYSHAK NUCLEUS	Aug 31, 2012	Substantially Equivalent	NUMED, INC.
K122394	RUBICON 18 SUPPORT CATHETER	Aug 30, 2012	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K121611	AMPLATZER TORQVUE FX	Aug 23, 2012	Substantially Equivalent	AGA MEDICAL CORPORATION
K121352	ARMADA 14XXT PTA CATHETER	Aug 15, 2012	Substantially Equivalent	Abbott Vascular
K120781	CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH	Aug 09, 2012	Substantially Equivalent	FUJI SYSTEMS CORP.
K121839	UNBALLOON NON-OCCLUSIVE MODELING CATHETER	Aug 08, 2012	Substantially Equivalent	LEMAITRE VASCULAR INC.
K120585	CONVEY GUIDING CATHETER	Aug 08, 2012	Substantially Equivalent	PENDRACARE INTERNATIONAL, B.V.
K121051	CONCIERGE GUIDING CATHETER	Jun 13, 2012	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K120964	UPSTREAM GR CATHETER	May 25, 2012	Substantially Equivalent	UPSTREAM PERIPHERAL TECHNOLOGIES
K120707	SWITCH-IT CATHETER	May 15, 2012	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K120296	CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER	May 11, 2012	Substantially Equivalent	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
K113778	EXCELSIOR XT-27 MICROCATHETER	Apr 20, 2012	Substantially Equivalent	STRYKER NEUROVASCULAR
K112100	M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER	Mar 20, 2012	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K120120	AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH	Mar 15, 2012	Substantially Equivalent	AGA MEDICAL CORPORATION
K112404	CONCENTRIC BALLOON GUIDE CATHETER	Mar 15, 2012	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K120381	Q50 PLUS STENT GRAFT BALLOON CATHETER	Feb 24, 2012	Substantially Equivalent	QXMEDICAL, LLC
K120229	ENVOY DISTAL ACCESS GUIDING CATHETER	Feb 24, 2012	Substantially Equivalent	Codman & Shurtleff, Inc.
K112886	UPSTREAM SUPPORT CATHETER	Feb 23, 2012	Substantially Equivalent	UPSTREAM PERIPHERAL TECHNOLOGIES
K120178	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	Feb 08, 2012	Substantially Equivalent	REFLOW MEDICAL
K120129	MANTARAY CATHETER	Feb 03, 2012	Substantially Equivalent	BRIDGEPOINT MEDICAL
K102439	FUNNEL GUIDE CATHETER MODEL G1020608	Jan 12, 2012	Substantially Equivalent	LAZARUS EFFECT, INC
K112035	VALET MICRO CATHETER	Jan 05, 2012	Substantially Equivalent	VOLCANO CORPORATION
K113589	BIGBOSS CATHETER	Jan 04, 2012	Substantially Equivalent	BRIDGEPOINT MEDICAL
K111738	CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)	Dec 14, 2011	Substantially Equivalent	TRIREME MEDICAL, INC.
K112082	GUIDELINER V2 CATHETER	Dec 01, 2011	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K113112	CLEARWAY RX NB CATHETER	Nov 17, 2011	Substantially Equivalent	ATRIUM MEDICAL CORP.
K112303	RUBICON SUPPORT CATHETER	Nov 09, 2011	Substantially Equivalent	BOSTON SCIENTIFIC
K112262	REFLEX BALLON GUIDE CATHETER	Nov 02, 2011	Substantially Equivalent	REVERSE MEDICAL CORPORATION
K112917	ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID	Oct 27, 2011	Substantially Equivalent	MEDTRONIC, INC.
K112828	REVIVE INTERMEDIATE CATHETER (REVIVE IC)	Oct 25, 2011	Substantially Equivalent	Codman & Shurtleff, Inc.
K112032	8FR TURBO - TANDEM SYSTEM	Oct 17, 2011	Substantially Equivalent	SPECTRANETICS CORP.
K112335	BANTAM CATHETER (280MM BALLOON LENGTHS)	Oct 12, 2011	Substantially Equivalent	CLEAR STREAM TECHNOLOGIES, LTD.
K112629	ONSET ACCESS CATHETER SYSTEM	Oct 11, 2011	Substantially Equivalent	ONSET MEDICAL CORPORATION
K112579	WILDCAT 5F GUIDEWIRE SUPPORT CATHETER	Oct 06, 2011	Substantially Equivalent	AVINGER, INC.
K112482	SELECTRA SLITTER TOOL	Sep 26, 2011	Substantially Equivalent	BIOTRONIK, INC.
K111839	SELECTRA ACCESSORY KIT	Sep 26, 2011	Substantially Equivalent	BIOTRONIK, INC.
K110891	THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER	Sep 13, 2011	Substantially Equivalent	LEMAITRE VASCULAR INC.
K111704	AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX	Sep 09, 2011	Substantially Equivalent	AVINGER, INC.
K112281	GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX	Aug 17, 2011	Substantially Equivalent	TRIREME MEDICAL, INC.
K111963	BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER	Aug 10, 2011	Substantially Equivalent	BRIDGEPOINT MEDICAL
K110813	HEADWAY 27 MICROCATHETER	Aug 05, 2011	Substantially Equivalent	MICRO VENTION, INC.
K111334	BENELLI ACCESS DEVICE	Aug 01, 2011	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K111556	GLIDECROSS SUPPORT CATHETER	Jul 29, 2011	Substantially Equivalent	TERUMO MEDICAL CORP.
K111750	EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE	Jul 21, 2011	Substantially Equivalent	ANGIOSLIDE, LTD
K111380	NEURON MAX SYSTEM	Jul 19, 2011	Substantially Equivalent	PENUMBRA, INC.
K111850	VACCESS PTA DILATATION CATHETER	Jul 13, 2011	Substantially Equivalent	C.R. BARD, INC.
K111252	ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F	Jun 02, 2011	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K111154	SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75	May 23, 2011	Substantially Equivalent	BIOTRONIK, INC.
K110540	TERUMO SUPPORT CATHETER	May 13, 2011	Substantially Equivalent	TERUMO MEDICAL CORP.
K102725	CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M	May 10, 2011	Substantially Equivalent	BRIDGE MEDICAL, INC.
K110461	SELECTRA CS LEAD INTRODUCER SYSTEM	Apr 20, 2011	Substantially Equivalent	BIOTRONIK, INC.
K102418	REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM	Apr 15, 2011	Substantially Equivalent	REVERSE MEDICAL CORPORATION
K110055	REVERSE MEDICAL REFLEX GUIDE CATHETER	Apr 05, 2011	Substantially Equivalent	REVERSE MEDICAL CORPORATION
K110483	MODIFIED HD GUIDE CATHETER	Apr 04, 2011	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K100184	FUSTAR STEERABLE INTRODUCERS	Feb 14, 2011	Substantially Equivalent	LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.
K103386	MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS	Feb 11, 2011	Substantially Equivalent	MEDTRONIC INC.
K103250	CPS DIRECT SL II SLITTABLE OUTER CATHETER	Jan 19, 2011	Substantially Equivalent	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
K102979	NEXGEN PERIPHERAL GUIDE CATHETER	Jan 18, 2011	Substantially Equivalent	NEXGEN MEDICAL SYSTEMS, INC.
K103534	GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE	Jan 05, 2011	Substantially Equivalent	TRIREME MEDICAL, INC.
K101659	SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301	Dec 16, 2010	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K103367	SEEKER CROSSING SUPPORT CATHETER	Dec 08, 2010	Substantially Equivalent	BARD PERIPHERAL VASCULAR, INC.
K102657	CONCENTRIC BALLOON GUIDE CATHETER	Nov 17, 2010	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K101015	GUIDE CATHETERS AND ACCESSORIES	Sep 23, 2010	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K101885	MEDTRONIC C315 DELIVERY CATHETER	Sep 09, 2010	Substantially Equivalent	MEDTRONIC INC.
K101479	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	Aug 11, 2010	Substantially Equivalent	REFLOW MEDICAL
K102022	WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S	Aug 06, 2010	Substantially Equivalent	AVINGER, INC.
K101877	OCCLUSION BALLOON CATHETER MODEL OBC	Aug 06, 2010	Substantially Equivalent	COOK, INC.
K101647	WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500	Aug 06, 2010	Substantially Equivalent	AVINGER, INC.
K101591	STINGRAY ORIENTING BALLOON CATHETER	Aug 06, 2010	Substantially Equivalent	BRIDGEPOINT MEDICAL
K101542	HEADWAY 17 ADVANCED MICROCATHETER	Aug 06, 2010	Substantially Equivalent	MICROVENTION, INC.
K101776	SCOUTPRO ACS	Jul 23, 2010	Substantially Equivalent	BIOTRONIK, INC.
K101282	SCOUTPRO HEMOSTATIC VALVE	Jul 21, 2010	Substantially Equivalent	BIOTRONIK, INC.
K101117	LEV-OR DILATION CATHETER OTW	Jul 16, 2010	Substantially Equivalent	BAYLIS MEDICAL CO., INC.
K100826	PENUMBRA CATHERER 025	Jul 13, 2010	Substantially Equivalent	PENUMBRA, INC.
K093977	ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX	Apr 22, 2010	Substantially Equivalent	CHESTNUT MEDICAL TECHNOLOGIES, INC.
K093431	CLEARWAY OTW MODEL 85912	Apr 20, 2010	Substantially Equivalent	ATRIUM MEDICAL CORP.
K100135	GDS-DC12	Apr 16, 2010	Substantially Equivalent	GUIDED DELIVERY SYSTEMS
K093969	ACUITY BREAK-AWAY GUIDE CATHETER	Mar 05, 2010	Substantially Equivalent	CARDIAC PACEMAKERS, INC.
K091188	ASAHI ZENYTEEX GUIDING CATHETER	Feb 26, 2010	Substantially Equivalent	ASAHI INTECC CO., LTD.
K094019	GLIDER PTA BALLOON CATHETER	Feb 12, 2010	Substantially Equivalent	TRIREME MEDICAL INC
K093476	AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120	Feb 05, 2010	Substantially Equivalent	AGA MEDICAL CORP.
K092174	ENABLER-P CATHETER SYSTEM, MODEL 3000	Dec 30, 2009	Substantially Equivalent	ENDOCROSS, LTD.
K093050	ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520	Dec 18, 2009	Substantially Equivalent	ARROW INTL., INC.
K093303	SCOUTPRO 7F LONG CATHETERS	Nov 20, 2009	Substantially Equivalent	BIOTRONIK, INC.
K093184	ENVOY GUIDING CATHETERS	Nov 06, 2009	Substantially Equivalent	Codman & Shurtleff, Inc.
K093160	HEADWAY 21 MICROCATHETER, MODEL: MC212150S	Nov 05, 2009	Substantially Equivalent	MICROVENTION, INC.
K092298	MODIFICATION TO MODIFIED HD GUIDE CATHETER	Nov 05, 2009	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K091750	GUIDELINER CATHETER, MODELS 5571, 5572, 5573	Nov 04, 2009	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K091624	STENT GRAFT BALLOON CATHETER	Oct 15, 2009	Substantially Equivalent	VIA BIOMEDICAL, INC.
K092396	SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS	Sep 04, 2009	Substantially Equivalent	SPECTRANETICS CORP.
K091841	BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000	Sep 02, 2009	Substantially Equivalent	BRIDGEPOINT MEDICAL
K092299	TRAILBLAZER SUPPORT CATHETER	Aug 07, 2009	Substantially Equivalent	EV3 INC
K092075	CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005	Aug 07, 2009	Substantially Equivalent	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
K090918	NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER	Jul 30, 2009	Substantially Equivalent	NFOCUS NEUROMEDICAL, INC.
K091793	AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54	Jul 09, 2009	Substantially Equivalent	AGA MEDICAL CORP.
K091299	SPECTRANETICS TURBO-TANDEM SYSTEM	Jul 01, 2009	Substantially Equivalent	SPECTRANETICS CORP.
K090613	CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2	Jul 01, 2009	Substantially Equivalent	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
K090977	PIGGYBACK WIRE CONVERTER	Jun 18, 2009	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K091527	ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER	Jun 12, 2009	Substantially Equivalent	COOK, INC.
K091345	GOPHER GOLD CATHETER, MODEL 5620	Jun 12, 2009	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K091254	THE CROSSER 14 OTW CATHETER, MODEL CRU014	May 29, 2009	Substantially Equivalent	FLOWCARDIA, INC.
K083833	ENABLER-P CATHETER, 1000 PART NUMBER:1160	May 22, 2009	Substantially Equivalent	ENDOCROSS, LTD.
K081130	BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER	May 14, 2009	Substantially Equivalent	BRIDGEPOINT MEDICAL
K083214	AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100	May 12, 2009	Substantially Equivalent	AGA MEDICAL CORP.
K090335	HD GUIDE CATHETER	May 06, 2009	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K090913	CROSS-PILOT TURBO ELITE SUPPORT CATHETER	May 04, 2009	Substantially Equivalent	SPECTRANETICS CORP.
K090849	MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150	May 01, 2009	Substantially Equivalent	EV3 INC.
K090822	ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER	Apr 27, 2009	Substantially Equivalent	COOK, INC.
K090659	ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY	Mar 26, 2009	Substantially Equivalent	MEDTRONIC INC.
K090509	FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER	Mar 20, 2009	Substantially Equivalent	ABBOTT VASCULAR-VASCULAR SOLUTIONS
K083919	AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER	Mar 13, 2009	Substantially Equivalent	INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
K083596	REEKROSS FAMILY OR OTW PTA CATHETERS	Mar 02, 2009	Substantially Equivalent	CLEARSTREAM TECHNOLOGIES, LTD.
K083422	6F TAIGA GUIDING CATHETER	Feb 06, 2009	Substantially Equivalent	MEDTRONIC VASCULAR
K080987	BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES	Feb 06, 2009	Substantially Equivalent	BRIDGEPOINT MEDICAL
K083127	ASAHI CORSAIR MICROCATHETER	Feb 03, 2009	Substantially Equivalent	ASAHI INTECC CO., LTD.
K083313	WILDCAT 7F GUIDEWIRE SUPPORT CATHETER	Feb 02, 2009	Substantially Equivalent	AVINGER, INC.
K081878	LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM	Jan 27, 2009	Substantially Equivalent	LEMAITRE VASCULAR, INC.
K082337	MINNIE SUPPORT CATHETER	Jan 15, 2009	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K083657	CONQUEST PTA BALLOON DILATATION CATHETER	Dec 24, 2008	Substantially Equivalent	C.R. BARD, INC.
K082932	CPS AIM SL SLITTABLE INNER CATHETER	Dec 12, 2008	Substantially Equivalent	ST. JUDE MEDICAL
K082559	SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER	Dec 11, 2008	Substantially Equivalent	SPECTRANETICS CORP.
K082385	CHAPERON GUIDING CATHETER	Dec 11, 2008	Substantially Equivalent	MICROVENTION, INC.
K082561	SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS	Dec 10, 2008	Substantially Equivalent	SPECTRANETICS CORP.
K080428	ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY	Dec 09, 2008	Substantially Equivalent	MEDTRONIC INC.
K083343	HEADWAY 17 MICROCATHETER	Dec 04, 2008	Substantially Equivalent	MICROVENTION, INC.
K082854	NANOCORSS .014 OTW PTA DILATATION CATHETER	Dec 04, 2008	Substantially Equivalent	EV3 INC.
K082670	MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET	Dec 04, 2008	Substantially Equivalent	MEDTRONIC INC.
K083139	VIPERSPHERE PTA BALLOON CATHETER	Nov 25, 2008	Substantially Equivalent	CARDIOVASCULAR SYSTEMS, INC.
K083125	NEURON SELECT CATHETER SIZE 070	Nov 21, 2008	Substantially Equivalent	PENUMBRA, INC.
K082579	EVERCROSS .035 OTW PTA DILATATION CATHETER	Nov 20, 2008	Substantially Equivalent	EV3 INC.
K082339	ENABLER-P SUPPORT CATHETER	Nov 20, 2008	Substantially Equivalent	ENDOCROSS, LTD.
K082933	PASSEO-35 PTA CATHETER	Nov 03, 2008	Substantially Equivalent	BIOTRONIK, INC.
K082646	OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER	Nov 03, 2008	Substantially Equivalent	USCI IRELAND
K082290	NEURON DELIVERY CATHETER 070	Oct 31, 2008	Substantially Equivalent	PENUMBRA, INC.
K082868	MULLINS-X, MODEL 250X	Oct 24, 2008	Substantially Equivalent	NUMED, INC.
K081799	GORE TRI-LOBE BALLOON CATHETER	Oct 03, 2008	Substantially Equivalent	W. L. GORE & ASSOCIATES, INC.
K073700	6F PROXIS SYSTEM	Oct 02, 2008	Substantially Equivalent	ST. JUDE MEDICAL, INC.
K082524	MINI GHOST, MODEL: 507	Sep 26, 2008	Substantially Equivalent	NUMED, INC.
K080849	MICROSHEATH LP AND LP-AT	Jul 25, 2008	Substantially Equivalent	FLOWCARDIA, INC.
K080583	MODIFIED HD GUIDE CATHETER	Jul 18, 2008	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K081680	NUCLEUS-X, MODEL 230X	Jul 10, 2008	Substantially Equivalent	NUMED, INC.
K080994	AMPLATZER TORQVUE EXCHANGE SYSTEM	May 16, 2008	Substantially Equivalent	AGA MEDICAL CORP.
K080988	SCOUTPRO CS LEAD INTRODUCER SYSTEM	May 07, 2008	Substantially Equivalent	BIOTRONIK, INC.
K080757	AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM	Apr 18, 2008	Substantially Equivalent	AGA MEDICAL CORP.
K080360	ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER	Apr 08, 2008	Substantially Equivalent	ENDOLOGIX, INC.
K072329	SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED	Mar 25, 2008	Substantially Equivalent	BIOTRONIK, INC.
K080154	ACUITY UNIVERSAL CUTTER	Mar 20, 2008	Substantially Equivalent	CARDIAC PACEMAKERS, INC.
K070126	OCCLUSION BALLOON CATHETER	Feb 08, 2008	Substantially Equivalent	SENTREHEART INC.
K073289	MICROSHEATH XL CATHETERS	Jan 11, 2008	Substantially Equivalent	FLOWCARDIA, INC.
K073378	ADVANCE 18LP PTA DILATATION CATHETER	Dec 28, 2007	Substantially Equivalent	COOK, INC.
K072750	SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066	Dec 04, 2007	Substantially Equivalent	SPECTRANETICS CORP.
K072618	TWIN-PASS OTW CATHETER, MODEL 5201	Nov 21, 2007	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K072156	OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER	Nov 09, 2007	Substantially Equivalent	USCI IRELAND
K072313	AMPLATZER TORQVUE DELIVERY SYSTEM	Nov 02, 2007	Substantially Equivalent	AGA MEDICAL CORP.
K070502	RADIUS SNARE	Oct 04, 2007	Substantially Equivalent	RADIUS MEDICAL TECHNOLOGIES, INC.
K072283	DORADO PTA BALLOON DILATATION CATHETER	Sep 19, 2007	Substantially Equivalent	BARD PERIPHERAL VASCULAR, INC.
K072316	PRECIOUS PLUS GUIDE CATHETER	Sep 17, 2007	Substantially Equivalent	ASAHI INTECC CO., LTD.
K070970	NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F	Aug 17, 2007	Substantially Equivalent	PENUMBRA, INC.
K071665	SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552	Jul 18, 2007	Substantially Equivalent	BIOTRONIK, INC.
K062885	STRIDE MICROCATHETER	Jun 13, 2007	Substantially Equivalent	ASAHI INTECC CO., LTD.
K070372	GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610	Jun 01, 2007	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K063638	MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101	May 11, 2007	Substantially Equivalent	ST. JUDE MEDICAL
K070051	ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM	Apr 06, 2007	Substantially Equivalent	ACUMEN MEDICAL, INC.
K070238	AMPLATZER RELIANT CATHETER DELIVERY SYSTEM	Feb 28, 2007	Substantially Equivalent	AGA MEDICAL CORP.
K062868	THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02	Jan 19, 2007	Substantially Equivalent	FLOWCARDIA INC
K061680	ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER	Dec 15, 2006	Substantially Equivalent	ATRIUM MEDICAL CORP.
K061601	ASAHI PRECIOUS GUIDE CATHETER	Nov 17, 2006	Substantially Equivalent	ASAHI INTECC CO., LTD.
K063252	ATB ADVANCED PTA DILATATION CATHETER	Nov 14, 2006	Substantially Equivalent	COOK, INC.
K061416	SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74	Oct 25, 2006	Substantially Equivalent	MEDTRONIC VASCULAR
K062202	OCCLUSION BALLOON	Oct 20, 2006	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K062809	ADMIRAL XTREME PTA CATHETER	Oct 18, 2006	Substantially Equivalent	INVATEC INNOVATIVE TECHNOLOGIES
K062609	MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER	Oct 06, 2006	Substantially Equivalent	ANGIODYNAMICS, INC.
K060927	CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES	Oct 06, 2006	Substantially Equivalent	CERES MEDICAL SYSTEMS, L.L.C.
K062594	MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM	Sep 20, 2006	Substantially Equivalent	Boston Scientific Corporation
K062420	5F SHERPA ACTIVE NX GUIDE CATHETER	Sep 08, 2006	Substantially Equivalent	MEDTRONIC VASCULAR
K061480	ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM	Aug 21, 2006	Substantially Equivalent	MEDTRONIC IRELAND
K062084	7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67	Aug 18, 2006	Substantially Equivalent	ACUMEN MEDICAL, INC.
K042850	CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)	Aug 09, 2006	Substantially Equivalent	STEREOTAXIS, INC.
K061843	VENTURE WIRE CONTROL CATHETER, MODEL WCC	Aug 01, 2006	Substantially Equivalent	ST. JUDE MEDICAL
K061710	CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS	Jul 14, 2006	Substantially Equivalent	ST. JUDE MEDICAL
K060745	ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY	Jun 23, 2006	Substantially Equivalent	ASAHI INTECC CO., LTD.
K061119	ENPATH MEDICAL STEERABLE SHEATH	May 18, 2006	Substantially Equivalent	ENPATH MEDICAL, INC.
K053491	PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F	Apr 27, 2006	Substantially Equivalent	PENUMBRA, INC.
K060807	SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM	Apr 24, 2006	Substantially Equivalent	BIOTRONIK, INC.
K060327	VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER	Apr 12, 2006	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K060655	SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H	Apr 04, 2006	Substantially Equivalent	BIOTRONIK, INC.
K053431	ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM	Mar 16, 2006	Substantially Equivalent	MEDTRONIC IRELAND
K060572	MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM	Mar 15, 2006	Substantially Equivalent	Boston Scientific Corporation
K060418	8F SHERPA NX GUIDE CATHETER	Mar 15, 2006	Substantially Equivalent	MEDTRONIC VASCULAR
K053217	CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148	Mar 08, 2006	Substantially Equivalent	ST. JUDE MEDICAL
K053277	CPS DIRECT SL OUTER CATHETER	Feb 24, 2006	Substantially Equivalent	ST. JUDE MEDICAL
K052004	VASCON NEUROPATH GUIDING CATHETER	Jan 19, 2006	Substantially Equivalent	VASCON LLC
K053118	STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX	Dec 16, 2005	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K053116	STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX	Dec 16, 2005	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K052258	VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER	Dec 13, 2005	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K052257	VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER	Nov 23, 2005	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K052791	MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER	Nov 04, 2005	Substantially Equivalent	INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
K051580	VP SHEATH	Oct 31, 2005	Substantially Equivalent	FLOWCARDIA, INC.
K051772	ASAHI TORNUS SUPPORT CATHETER	Sep 26, 2005	Substantially Equivalent	ASAHI INTECC CO., LTD.
K052149	EDWARDS PERIPHERAL DILATION CATHETER	Sep 02, 2005	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K051838	MODIFIED CONCENTRIC RETRIEVER, MODEL 90039	Sep 01, 2005	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K052036	ATB ADVANCE PTA DILATATION CATHETER	Aug 25, 2005	Substantially Equivalent	COOK, INC.
K052236	BARD ATLAS PTA BALLOON DILATATION CATHETER	Aug 23, 2005	Substantially Equivalent	BARD PERIPHERAL VASCULAR, INC.
K051846	7F SHERPA NX GUIDE CATHETER	Aug 05, 2005	Substantially Equivalent	MEDTRONIC VASCULAR
K051343	MINI GHOST PTA CATHETER, MODEL 507	Jul 28, 2005	Substantially Equivalent	NUMED, INC.
K050599	TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER	Jun 03, 2005	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K051060	ANGIODYNAMICS PROFILER PTA BALLOON CATHETER	May 26, 2005	Substantially Equivalent	ANGIODYNAMICS, INC.
K050389	ULTRA-SOFT SV BALLOON DILATATION CATHETER	May 25, 2005	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K043489	ENPATH DEFLECTABLE CATHETER	May 19, 2005	Substantially Equivalent	ENPATH MEDICAL INCORPORATED
K050038	RELIANT STENT GRAFT BALLOON CATHETER	Apr 13, 2005	Substantially Equivalent	MEDTRONIC ENDOVASCULAR INNOVATIONS
K043580	ALLIGATOR RETRIEVAL DEVICE (ARD)	Mar 24, 2005	Substantially Equivalent	CHESTNUT MEDICAL TECHNOLOGIES, INC.
K042553	BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER	Feb 17, 2005	Substantially Equivalent	BIOCARDIA, INC.
K043387	VASCON POLARIS GUIDING CATHETER	Feb 16, 2005	Substantially Equivalent	VASCON LLC
K050073	MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER	Feb 11, 2005	Substantially Equivalent	INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
K043534	MODIFICATION TO OUTBACK CATHETER	Jan 21, 2005	Substantially Equivalent	LUMEND, INC.
K042624	AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER	Jan 10, 2005	Substantially Equivalent	INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
K042117	PROXIS SYSTEM, MODEL EPS 101	Jan 07, 2005	Substantially Equivalent	VELOCIMED INC.
K042381	CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508	Dec 28, 2004	Substantially Equivalent	ACUMEN MEDICAL, INC.
K042489	6F Z4 GUIDE CATHETER	Dec 13, 2004	Substantially Equivalent	MEDTRONIC VASCULAR
K042910	VENTURE WIRE CONTROL CATHETER, MODEL WCC	Nov 22, 2004	Substantially Equivalent	VELOCIMED INC.
K042538	SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX	Nov 08, 2004	Substantially Equivalent	INVATEC INNOVATIVE TECHNOLOGIES
K042537	SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX	Nov 08, 2004	Substantially Equivalent	INVATEC INNOVATIVE TECHNOLOGIES
K042230	POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM	Nov 05, 2004	Substantially Equivalent	CRYOVASCULAR SYSTEMS, INC.
K042388	RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE	Oct 28, 2004	Substantially Equivalent	RADIANT MEDICAL
K042568	EXCELSIOR 1018 AND SL-10 MICROCATHETERS	Oct 15, 2004	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K042541	MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM	Oct 12, 2004	Substantially Equivalent	CRYOVASCULAR SYSTEMS, INC.
K042194	ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY	Sep 15, 2004	Substantially Equivalent	MEDTRONIC VASCULAR
K040922	VENTURE WIRE CONTROL CATHETER	Aug 18, 2004	Substantially Equivalent	VELOCIMED INC.
K040745	MODIFIED CONCENTRIC RETRIEVER, MODEL 90038	Aug 11, 2004	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K041151	KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES	Jul 22, 2004	Substantially Equivalent	KERBEROS PROXIMAL SOLUTIONS, INC.
K040700	CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037	Jun 21, 2004	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K033540	TRANSXCHANGE SUPPORT CATHETER	May 25, 2004	Substantially Equivalent	MEDTRONIC VASCULAR
K041093	NUMED MULLINS X PTA CATHETER	May 06, 2004	Substantially Equivalent	NUMED, INC.
K033670	GORE TRI-LOBE BALLOON CATHETER	May 05, 2004	Substantially Equivalent	W. L. GORE & ASSOCIATES, INC.
K040771	MODIFICATION TO OUTBACK CATHETER	Apr 23, 2004	Substantially Equivalent	LUMEND, INC.
K033875	ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER	Apr 02, 2004	Substantially Equivalent	COOK, INC.
K040481	SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1	Mar 18, 2004	Substantially Equivalent	INTRALUMINAL THERAPEUTICS, INC.
K033678	SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038	Feb 23, 2004	Substantially Equivalent	SPECTRANETICS CORP.
K033633	VASCON POLARIS GUIDING CATHETER	Feb 18, 2004	Substantially Equivalent	VASCON LLC
K040243	BARD ATLAS PTA BALLOON DILATATION CATHETER	Feb 13, 2004	Substantially Equivalent	C.R. BARD, INC.
K033622	POLARCATH PERIPHERAL DILATATION SYSTEM	Feb 10, 2004	Substantially Equivalent	CRYOVASCULAR SYSTEMS, INC.
K033989	MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69	Jan 22, 2004	Substantially Equivalent	MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT
K033441	BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER	Nov 21, 2003	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K033320	SCOUT PRO	Nov 19, 2003	Substantially Equivalent	BIOTRONIK, INC.
K032869	COOK CODA BALLOON CATHETER	Nov 19, 2003	Substantially Equivalent	COOK, INC.
K032784	ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1	Nov 18, 2003	Substantially Equivalent	INTRALUMINAL THERAPEUTICS, INC.
K033217	PHERON PTA CATHETER	Oct 31, 2003	Substantially Equivalent	BIOTRONIK, INC.
K032660	XTRAK SUPPORT CATHETER	Oct 29, 2003	Substantially Equivalent	XTRAK MEDICAL INC.
K032931	PTA BALLOON CATHETER	Oct 22, 2003	Substantially Equivalent	COOK, INC.
K032312	ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM	Oct 21, 2003	Substantially Equivalent	MEDTRONIC VASCULAR
K032737	CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA	Oct 02, 2003	Substantially Equivalent	CORDIS EUROPA N.V.
K032587	EDWARDS PERIPHERAL DILATATION CATHETER	Oct 02, 2003	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K032591	NUMED TYSHAK MINI PEDIATRIC PTV CATHETER	Sep 25, 2003	Substantially Equivalent	NUMED, INC.
K032622	ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS	Sep 03, 2003	Substantially Equivalent	MEDTRONIC VASCULAR
K030630	EDWARDS DIRECTIONAL CATHETER	Sep 03, 2003	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K032069	WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER	Aug 27, 2003	Substantially Equivalent	ANGIODYNAMICS, INC.
K032298	MODIFICATION TO OUTBACK CATHETER	Aug 26, 2003	Substantially Equivalent	LUMEND, INC.
K031692	SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1	Aug 22, 2003	Substantially Equivalent	INTRALUMINAL THERAPEUTICS, INC.
K023548	PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101	Aug 04, 2003	Substantially Equivalent	VELOCIMED
K030671	MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB	Jul 31, 2003	Substantially Equivalent	MEDTRONIC VASCULAR
K031459	RAPIDO CUT-AWAY CUTTER	Jul 23, 2003	Substantially Equivalent	GUIDANT CORP.
K031211	ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH	Jul 17, 2003	Substantially Equivalent	MEDTRONIC VASCULAR
K031417	ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1	Jul 11, 2003	Substantially Equivalent	INTRALUMINAL THERAPEUTICS, INC.
K031766	ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER	Jun 26, 2003	Substantially Equivalent	COOK, INC.
K031505	RAPIDO CUT-AWAY GUIDING CATHETER	Jun 25, 2003	Substantially Equivalent	GUIDANT CORPORATION
K030589	MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS	May 21, 2003	Substantially Equivalent	NUMED, INC.
K030984	SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT	Apr 24, 2003	Substantially Equivalent	INTRALUMINAL THERAPEUTICS, INC.
K030779	5F MEDTRONIC LAUNCHER GUIDE CATHETER	Apr 24, 2003	Substantially Equivalent	MEDTRONIC VASCULAR
K030715	SAFFRON NM GUIDING CATHETER	Apr 24, 2003	Substantially Equivalent	NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
K021802	STEREOTAXIS CATHETER ADVANCER SYSTEM	Apr 08, 2003	Substantially Equivalent	STEREOTAXIS, INC.
K024327	SETPOINT ENDOVASCULAR TEMPERATURE PROBE	Mar 25, 2003	Substantially Equivalent	RADIANT MEDICAL
K030476	MODIFIED CONCENTRIC RETRIEVER, MODEL 90037	Mar 11, 2003	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K023463	CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT	Feb 19, 2003	Substantially Equivalent	CRYOVASCULAR SYSTEMS, INC.
K024035	ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY	Dec 30, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K024032	ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY	Dec 30, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K023320	AGILTRAC .035 PERIPHERAL DILATATION CATHETER	Dec 10, 2002	Substantially Equivalent	GUIDANT CORP.
K023402	8F LAUNCHER GUIDE CATHETER	Nov 06, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K023223	MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER	Oct 24, 2002	Substantially Equivalent	LUMEND, INC.
K022552	ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER	Sep 27, 2002	Substantially Equivalent	COOK, INC.
K022138	SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028	Sep 23, 2002	Substantially Equivalent	SPECTRANETICS CORP.
K022061	CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER	Sep 20, 2002	Substantially Equivalent	CRYO VASCULAR SYSTEMS INC.
K022738	AGILTRAC .035 PERIPHERAL DILATATION CATHETER	Sep 13, 2002	Substantially Equivalent	GUIDANT CORP.
K022722	PTA AND PTV	Sep 13, 2002	Substantially Equivalent	NUMED, INC.
K022764	7F LAUNCHER GUIDE CATHETER	Aug 28, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K021735	BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER	Aug 08, 2002	Substantially Equivalent	BOSTON SCIENTIFIC SCIMED, INC.
K021455	RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,	Aug 02, 2002	Substantially Equivalent	GUIDANT CORP.
K021899	CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072	Jul 10, 2002	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K021721	EQUALIZER BALLOON CATHETER	Jun 20, 2002	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K021593	MODIFICATION TO ENVOY AND VISTA BRITE TIP	Jun 13, 2002	Substantially Equivalent	CORDIS CORP.
K021589	ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218	May 30, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K021587	ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A	May 30, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K021256	Z3 GUIDE CATHETER	May 17, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K021284	EASYTRAK GUIDING CATHETER	May 02, 2002	Substantially Equivalent	GUIDANT CORP.
K021120	RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP	May 02, 2002	Substantially Equivalent	ARROW INTL., INC.
K021088	JOGUIDE CARDIOVASCULAR GUIDING C ATHETER	May 02, 2002	Substantially Equivalent	JOMED CATHETER, INC.
K013517	10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600	Apr 25, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K013963	MODEL 9210 DELIVERY CATHETER, MODEL 9210	Feb 28, 2002	Substantially Equivalent	MEDTRONIC VASCULAR
K020161	AGILTRAC .018 PERIPHERAL DILATATION CATHETER	Feb 22, 2002	Substantially Equivalent	GUIDANT CORP.
K013284	LUMEND FRONTRUNNER CTO CORONARY CATHETER	Feb 11, 2002	Substantially Equivalent	LUMEND, INC.
K020028	6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX	Jan 22, 2002	Substantially Equivalent	BOSTON SCIENTIFIC
K014212	BARD CONQUEST PTA BALLOON DILATATION CATHETER	Jan 17, 2002	Substantially Equivalent	C.R. BARD, INC.
K011562	LUMEND PERCUTANEOUS CATHETER	Jan 16, 2002	Substantially Equivalent	LUMEND, INC.
K014118	MODIFICATION TO SUPERCROSS CATHETER	Jan 11, 2002	Substantially Equivalent	ABBOTT VASCULAR INC.
K014117	MODIFICATION TO OUTBACK CATHETER	Jan 11, 2002	Substantially Equivalent	LUMEND, INC.
K013601	NUMED MULLINS PTA CATHETER	Jan 03, 2002	Substantially Equivalent	NUMED, INC.
K011889	ULTRA -THIN SDS BALLOON DILATATION CATHETER	Dec 21, 2001	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K013789	EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189	Dec 06, 2001	Substantially Equivalent	BOSTON SCIENTIFIC, TARGET
K013638	MODIFICATION TO VIKING OPTIMA GUIDING CATHETER	Dec 04, 2001	Substantially Equivalent	GUIDANT CORP.
K013581	CORDIS AVIATOR PERIPHERAL DILATATION CATHETER	Nov 28, 2001	Substantially Equivalent	CORDIS, A JOHNSON & JOHNSON CO.
K010579	STENT SUPPORT GUIDE CATHETER	Nov 21, 2001	Substantially Equivalent	MEDTRONIC VASCULAR
K010954	CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031	Oct 09, 2001	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K012913	BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER	Sep 28, 2001	Substantially Equivalent	C.R. BARD, INC.
K012050	VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER	Sep 06, 2001	Substantially Equivalent	GUIDANT CORP.
K012169	ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1	Aug 30, 2001	Substantially Equivalent	INTRALUMINAL THERAPEUTICS, INC.
K012130	ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM	Aug 28, 2001	Substantially Equivalent	MEDTRONIC VASCULAR
K012083	ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218	Aug 28, 2001	Substantially Equivalent	MEDTRONIC VASCULAR
K012002	VIKING OPTIMA GUIDING CATHETER	Jul 26, 2001	Substantially Equivalent	GUIDANT CORP.
K010874	6F MACH 1, MODEL 34356-XXX	Jun 21, 2001	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K010838	FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008	Jun 21, 2001	Substantially Equivalent	JOMED AG
K003920	CORDIS M3 PTA DILATATION CATHETER	Jun 15, 2001	Substantially Equivalent	CORDIS CORP.
K011464	RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN	Jun 13, 2001	Substantially Equivalent	VASCULAR INTERVENTION
K010831	AVIATOR PERIPHERAL DILATATION CATHETER	Jun 13, 2001	Substantially Equivalent	GUIDANT CORP.
K003410	CONCENTRIC RETRIEVER, MODEL 90030	May 22, 2001	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K003880	CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)	May 16, 2001	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K001694	GUIDANT RETRIEVER DEVICE	May 15, 2001	Substantially Equivalent	GUIDANT CARDIAC AND VASCULAR SURGERY
K010880	NUMED HIGH PRESSURE PTA CATHETERS	Apr 20, 2001	Substantially Equivalent	NUMED, INC.
K010853	GUIDER SOFTIP GUIDING CATHETER XF 5F	Apr 18, 2001	Substantially Equivalent	BOSTON SCIENTIFIC, TARGET
K010531	ILT DEFLECTING CATHETER, MODEL C114ND1	Apr 18, 2001	Substantially Equivalent	INTRALUMINAL THERAPEUTICS, INC.
K003085	CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020	Mar 07, 2001	Substantially Equivalent	CONCENTRIC MEDICAL, INC.
K001856	SUPERCROSS CATHETER	Mar 07, 2001	Substantially Equivalent	ABBOTT VASCULAR INC.
K010169	BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER	Feb 13, 2001	Substantially Equivalent	C.R. BARD, INC.
K003495	ANCURE LLIAC BALLOON CATHETER	Feb 07, 2001	Substantially Equivalent	GUIDANT CARDIAC AND VASCULAR SURGERY
K001577	OUTBACK CATHETER	Jan 11, 2001	Substantially Equivalent	LUMEND, INC.
K003643	NUMED Z-MED PTV CATHERERS	Dec 27, 2000	Substantially Equivalent	NUMED, INC.
K001992	ILT 0.014 CATHETER, MODEL C114NL2	Sep 25, 2000	Substantially Equivalent	INTRALUMINAL THERAPEUTICS, INC.
K001969	GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300	Aug 16, 2000	Substantially Equivalent	MEDTRONIC VASCULAR
K001435	VIKING OPTIMA GUIDING CATHETER	Jun 02, 2000	Substantially Equivalent	GUIDANT CORP.
K001136	CORDIS INTRODUCER GUIDE	Apr 28, 2000	Substantially Equivalent	CORDIS CORP.
K000715	ENVOY AND VISTA BRITE TIP	Mar 31, 2000	Substantially Equivalent	CORDIS CORP.
K000677	ZUMA GUIDE CATHETERS	Mar 29, 2000	Substantially Equivalent	MEDTRONIC VASCULAR
K000598	5F GUIDING CATHETER	Mar 24, 2000	Substantially Equivalent	GUIDANT CORP.
K994229	VERIPATH PERIPHERAL GUIDING CATHETER	Feb 25, 2000	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K991059	SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017	Nov 16, 1999	Substantially Equivalent	SPECTRANETICS CORP.
K991601	DUAL LUMEN CATHETER, MODEL DL-35-90	Oct 28, 1999	Substantially Equivalent	ENDOLOGIX, INC.
K992673	VISTA BRITE TIP CATHETERS	Oct 12, 1999	Substantially Equivalent	CORDIS CORP.
K992622	INTRAMAX ITI GUIDE CATHETER	Sep 29, 1999	Substantially Equivalent	INTRATHERAPEUTICS, INC.
K984482	AVE GL-1 GUIDING CATHETER	Jul 30, 1999	Substantially Equivalent	ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC.
K974683	NAVIPORT DEFLECTABLE TIP GUIDING CATHETER	Jun 22, 1999	Substantially Equivalent	CARDIMA, INC.
K981191	ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65	Apr 07, 1999	Substantially Equivalent	INTRATHERAPEUTICS, INC.
K990726	ENVY GUIDING CATHETER	Apr 02, 1999	Substantially Equivalent	COOK, INC.
K990707	MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS	Mar 22, 1999	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K981359	GT LEGGIERO	Jan 27, 1999	Substantially Equivalent	TERUMO MEDICAL CORP.
K972065	AURORA	Jan 27, 1999	Substantially Equivalent	NEUROVENA CORP.
K980278	URESIL VASCU-FLO INFUSION CATHETER	Nov 20, 1998	Substantially Equivalent	URESIL CORP.
K982883	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	Sep 04, 1998	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K982770	6F ENVOY GUIDING CATHETER	Aug 18, 1998	Substantially Equivalent	CORDIS CORP.
K982632	ENVOY AND VISTA BRITE TIP	Aug 18, 1998	Substantially Equivalent	CORDIS CORP.
K980453	SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS	Aug 11, 1998	Substantially Equivalent	BOSTON SCIENTIFIC SCIMED, INC.
K981198	MEDTRONIC ZUMA GUIDING CATHETER	Aug 07, 1998	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K973298	CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER	Jun 26, 1998	Substantially Equivalent	CARDIMA, INC.
K970668	THE AMPLANTZ GOOSE NECK MICROSNARE	Jun 10, 1998	Substantially Equivalent	MICROVENA CORP.
K981413	SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS	May 13, 1998	Substantially Equivalent	BOSTON SCIENTIFIC SCIMED, INC.
K974684	SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER	Feb 19, 1998	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K973371	CERTODYN RAECG UNIVERSAL ADAPTER	Nov 24, 1997	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K972978	VISTA BRITE TIP GUIDING CATHETERS	Oct 21, 1997	Substantially Equivalent	CORDIS CORP.
K972484	ACS VIKING GUIDING CATHETER	Sep 26, 1997	Substantially Equivalent	GUIDANT CORP.
K970401	MEDI-DYNE GUIDING CATHETER	Aug 01, 1997	Substantially Equivalent	MEDI-DYNE, INC.
K965247	ENVOY GUIDING CATHETER	Jul 23, 1997	Substantially Equivalent	CORDIS NEUROVASCULAR, INC.
K971572	VISTA BRITE TIP CATHETERS	Jul 14, 1997	Substantially Equivalent	CORDIS CORP.
K970823	SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER	Jun 03, 1997	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K963962	VISTA BRITE TIP CATHETERS	May 07, 1997	Substantially Equivalent	CORDIS CORP.
K965211	VISTA BRITE TIP CATHETERS	Mar 11, 1997	Substantially Equivalent	CORDIS CORP.
K962717	6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING	Feb 12, 1997	Substantially Equivalent	BIOCOMPATIBLES CARDIOVASCULAR, INC.
K963663	11F GUIDING CATHETER	Jan 13, 1997	Substantially Equivalent	BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
K962830	VISTA BRITE TIP CATHETERS	Oct 17, 1996	Substantially Equivalent	CORDIS CORP.
K962362	CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS	Aug 08, 1996	Substantially Equivalent	CORDIS CORP.
K961280	SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F	May 15, 1996	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K955651	MEDTRONIC SHERPA GUIDING CATHETER	Jan 22, 1996	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K953265	SCIMED ANGIOGRAPHIC KITS	Jan 16, 1996	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K953987	ACS TOURGIDE GUIDING CATHETER	Dec 07, 1995	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K950490	MEDTRONIC GC IV CORONARY GUIDING CATHETER	Nov 21, 1995	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K953909	SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER	Nov 13, 1995	Substantially Equivalent	SCIMED
K954251	5F ENVOY GUIDING CATHETER (MODIFICATION)	Oct 23, 1995	Substantially Equivalent	CORDIS NEUROVASCULAR, INC.
K951603	CARDIMA, INC. FORERUNNER	Oct 05, 1995	Substantially Equivalent	CARDIMA, INC.
K951159	FASGUIDE	Sep 25, 1995	Substantially Equivalent	TARGET THERAPEUTICS
K953515	SCIMED TRIGUIDE GUIDE CATHETERS	Sep 19, 1995	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K952345	MEDI-TECH PLATFORM GUIDE CATHETER	Aug 17, 1995	Substantially Equivalent	MEDI-TECH, INC.
K952205	ACS POWERBASE GUILDING CATHETER	Aug 04, 1995	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K952185	CORDIS BRITE TIP, ENVOY GUIDING CATHETER	Aug 02, 1995	Substantially Equivalent	CORDIS CORP.
K950179	MEDTRONIC(R) GC III CORONARY GUIDING CATHETER	Jul 25, 1995	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K946272	SCIMED(R) COURIER GUIDE CATHETER	Apr 17, 1995	Substantially Equivalent	SCIMED PERIPHERAL INTERVENTIONS
K950047	SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER	Apr 05, 1995	Substantially Equivalent	ISOMEDIX OPERATIONS INC.
K950026	MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER	Apr 05, 1995	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K946204	SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS	Mar 13, 1995	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K950094	SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER	Mar 03, 1995	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K944668	SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS	Mar 03, 1995	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K950635	CANDEKA DUKATIR SETS	Mar 01, 1995	Substantially Equivalent	CANDELA LASER CORP.
K950634	CANDELA SHEATH SETS	Mar 01, 1995	Substantially Equivalent	CANDELA LASER CORP.
K945705	5F ENVOY(TM) GUIDING CATHETER	Feb 03, 1995	Substantially Equivalent	CORDIS NEUROVASCULAR, INC.
K943622	SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER	Nov 30, 1994	Substantially Equivalent	BOSTON SCIENTIFIC SCIMED, INC.
K944537	SCIMED TRIGUIDE GUIDE CATHETER	Oct 21, 1994	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K935597	FASGUIDE CATHETER	Oct 18, 1994	Substantially Equivalent	TARGET THERAPEUTICS
K943783	7 FRENCH LARGE LUMEN TRIGUIDE-PLUS	Oct 13, 1994	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K943777	SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER	Oct 13, 1994	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K941137	SCIMED TRIGUIDE GUIDING CATHETER	Jun 22, 1994	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K935292	SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER	Jun 10, 1994	Substantially Equivalent	BOSTON SCIENTIFIC SCIMED, INC.
K940545	SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH	May 06, 1994	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K935738	MEDTRONIC GCIII CORONARY GUIDING CATHETER	May 04, 1994	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K940559	ACS POWERBASE(TM) CORONARY GUIDING CATHETER	May 03, 1994	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K935425	METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS	Apr 26, 1994	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K940603	SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER	Apr 19, 1994	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K934685	SOFTTOUCH GUIDE CATHETER	Apr 07, 1994	Substantially Equivalent	MALLINCKRODT MEDICAL
K940187	ENVOY GUIDING CATHETER	Mar 30, 1994	Substantially Equivalent	CORDIS NEUROVASCULAR, INC.
K930476	GUIDING CATHETER	Feb 10, 1994	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K932933	GC IV CORONARY GUIDING CATHETER	Feb 01, 1994	Substantially Equivalent	MEDTRONICS INTERVENTIONAL VASCULAR
K934988	9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER	Jan 14, 1994	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K934009	ACS POWERGUIDE CORONARY GUIDING CATHETER	Jan 11, 1994	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K933019	USCI SUPER 6 6F PTCA GUIDING CATHETER	Sep 28, 1993	Substantially Equivalent	C.R. BARD, INC.
K925439	MICROSNARE	Sep 24, 1993	Substantially Equivalent	MICROVENA CORP.
K933033	GUIDING CATHETER HEMOSTASIS VALVE CAP	Sep 10, 1993	Substantially Equivalent	ARROW INTL., INC.
K932619	TRANSSEPTAL INTRODUCER SET	Aug 24, 1993	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K931403	SITERITE NEEDLE GUIDE (MODIFIED)	Jul 27, 1993	Substantially Equivalent	DYMAX CORP.
K925131	CORDIS 9 F GUIDING CATHETER	May 06, 1993	Substantially Equivalent	CORDIS CORP.
K922609	ITC CATHETERS W/ HYDROMER	Apr 30, 1993	Substantially Equivalent	INTERVENTIONAL THERAPEUTICS CORP.
K926421	ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH	Mar 23, 1993	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K923245	TRIGUIDE-PLUS GUIDING CATHETER	Feb 12, 1993	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K923518	GUIDING CATHETER	Jan 12, 1993	Substantially Equivalent	INTERVENTIONAL THERAPEUTICS CORP.
K922611	SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER	Jan 11, 1993	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K924591	SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER	Dec 08, 1992	Substantially Equivalent	SCHNEIDER INTL., LTD.
K921311	CORDIS SHUTTLE CATHETER W/ SIDEHOLES	Sep 09, 1992	Substantially Equivalent	CORDIS CORP.
K914984	E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION	May 20, 1992	Substantially Equivalent	E-Z-EM, INC.
K914856	VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)	May 01, 1992	Substantially Equivalent	COOK, INC.
K920331	RIGHT ATRIAL CATHETER KITS	Apr 22, 1992	Unknown	AKCESS MEDICAL PRODUCTS, INC.
K915521	TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED	Mar 23, 1992	Substantially Equivalent	TARGET THERAPEUTICS
K915374	CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER	Feb 14, 1992	Substantially Equivalent	CORDIS CORP.
K915777	CORDIS SHUTTLE CATHETER	Feb 11, 1992	Substantially Equivalent	CORDIS CORP.
K914422	DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE	Dec 18, 1991	Substantially Equivalent	DEVICES FOR VASCULAR INTERVENTION, INC.
K913830	SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS	Nov 22, 1991	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K913052	ITC GUIDING CATHETER	Nov 22, 1991	Substantially Equivalent	INTERVENTIONAL THERAPEUTICS CORP.
K913517	ISOLATE INFUSION CATHETR SYSTEM	Nov 05, 1991	Substantially Equivalent	LAKE REGION MFG., INC.
K913783	CORDIS PTCA GUIDING CATHETER, MODIFICATION	Oct 18, 1991	Substantially Equivalent	DOW CORNING WRIGHT
K911869	IVT GUIDING CATHETER	Oct 16, 1991	Substantially Equivalent	INTENSIVE TECHNOLOGY, INC.
K912877	PROFUSE INFUSION SYSTEM	Sep 23, 1991	Substantially Equivalent	LAKE REGION MFG., INC.
K911333	RIGHT ATRIAL CATHETERS	Sep 23, 1991	Substantially Equivalent	AKCESS MEDICAL PRODUCTS, INC.
K912777	CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER	Sep 20, 1991	Substantially Equivalent	CORDIS CORP.
K911747	PRO-GUIDE	Sep 18, 1991	Substantially Equivalent	AMERICAN INTERVENTIONAL TECHNOLOGY
K912564	MEGA PERICARDIOCENTESIS KIT	Sep 05, 1991	Substantially Equivalent	MEGA MEDICAL, INC.
K912199	SOFTTOUCH(R) GUIDING CATHETER	Jul 30, 1991	Substantially Equivalent	MALLINCKRODT MEDICAL
K912191	SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP	Jul 30, 1991	Substantially Equivalent	MALLINCKRODT MEDICAL
K910116	TURBO SUPPORT CATHETER	Jun 25, 1991	Substantially Equivalent	DATASCOPE CORP.
K911519	CATHCAP, CAT. NO. CC100 SERIES	May 22, 1991	Substantially Equivalent	GISH BIOMEDICAL, INC.
K911527	NOVOSTE GUIDING CATHETER	Apr 24, 1991	Substantially Equivalent	NOVOSTE CORP.
K905249	NEW USCI 7F PTCA GUIDING CATHETER	Feb 19, 1991	Substantially Equivalent	C.R. BARD, INC.
K904404	MULTI-LUMEN CENTRAL VENOUS CATHETER SET	Feb 15, 1991	Substantially Equivalent	ARROW INTL., INC.
K902256	IRRIGATION CATHETER 4, 6 AND 10 FRENCH	Feb 15, 1991	Substantially Equivalent	APPLIED VASCULAR DEVICES, INC.
K905720	PALMAZ BILIARY STENT	Feb 05, 1991	Substantially Equivalent	JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS
K905547	SOFTOUCH GUIDING CATHETER	Feb 05, 1991	Substantially Equivalent	MALLINCKRODT MEDICAL
K902999	VASCULAR RETRIEVAL FORCEPS	Feb 01, 1991	Substantially Equivalent	COOK, INC.
K904884	ACS URETHAN CORONARY GUIDING CATHETER	Jan 03, 1991	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K904608	PERCUTANEOUS INTRODUCER TRAY	Dec 03, 1990	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K902587	SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH	Dec 03, 1990	Substantially Equivalent	SCHNEIDER INTL., LTD.
K903330	MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER	Oct 23, 1990	Substantially Equivalent	MALLINCKRODT MEDICAL
K903217	TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER	Oct 19, 1990	Substantially Equivalent	INTEC MEDICAL, INC.
K903216	THE GUIDER CORONARY GUIDING CATHETER	Oct 19, 1990	Substantially Equivalent	INTEC MEDICAL, INC.
K903158	SITERITE NEEDLE GUIDE	Sep 27, 1990	Substantially Equivalent	DYMAX CORP.
K902905	COOK CORONARY GUIDING CATHETER	Sep 04, 1990	Substantially Equivalent	COOK, INC.
K900978	MANAN ARTERIAL CATHETER NEEDLE	Aug 23, 1990	Substantially Equivalent	MANAN MEDICAL PRODUCTS, INC.
K900998	INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE	Aug 14, 1990	Substantially Equivalent	INTEC MEDICAL, INC.
K900657	UNIVERSAL DELIVERY SYSTEM CATHETER	May 09, 1990	Substantially Equivalent	MICROVENA CORP.
K895972	CURITY(R) PERCUTANEOUS CATHETERS	Mar 13, 1990	Substantially Equivalent	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
K897082	SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR	Mar 06, 1990	Substantially Equivalent	SCHNEIDER INTL., LTD.
K895932	PSG(TM) EDM(TM) INFUSION CATHETER	Jan 04, 1990	Substantially Equivalent	PERIPHERAL SYSTEMS GROUP
K895440	QUINTON MAHURKAR CATHETERS W/VITACUFF	Nov 29, 1989	Substantially Equivalent	QUINTON, INC.
K895753	BREVET DISPOSABLE CONNECTORS	Nov 14, 1989	Substantially Equivalent	BREVET, INC.
K894105	TARGET THERAPEUTICS TRACKER LF CATHETER	Sep 28, 1989	Substantially Equivalent	TARGET THERAPEUTICS
K894131	DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000	Sep 26, 1989	Substantially Equivalent	THERMEDICS, INC.
K894682	USCI UNCOATED GUIDING CATHETERS	Sep 12, 1989	Substantially Equivalent	C.R. BARD, INC.
K894084	TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE	Aug 17, 1989	Substantially Equivalent	TARGET THERAPEUTICS
K890152	USCI PROBING CATHETER	Aug 17, 1989	Substantially Equivalent	C.R. BARD, INC.
K891069	USCI CORONARY INFUSION CATHETER	Aug 09, 1989	Substantially Equivalent	C.R. BARD, INC.
K884491	MEDIZIV CENTRAL VEIN CATHETER	Jun 05, 1989	Substantially Equivalent	MEDIZIV MEDICAL DEVICES, LTD.
K885237	ACS SELECTIVE INFUSION CATHETER	Mar 16, 1989	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K884209	USCI DORROS INFUSION/PROBING CATHETER	Dec 21, 1988	Substantially Equivalent	USCI, DIV. C.R. BARD, INC.
K884129	BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET	Dec 21, 1988	Substantially Equivalent	BIO MEDICUS, INC.
K883564	ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES	Nov 03, 1988	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K883916	ROTATING HEMOSTATIC VALVE	Oct 28, 1988	Substantially Equivalent	DEVICES FOR VASCULAR INTERVENTION, INC.
K881793	WILSON BIOMEDICAL CORONARY GUIDING CATHETER	Oct 19, 1988	Substantially Equivalent	WILSON BIOMEDICAL, INC.
K883174	MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE	Oct 14, 1988	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K882969	VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT	Sep 26, 1988	Substantially Equivalent	GISH BIOMEDICAL, INC.
K882803	ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST	Sep 16, 1988	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K881504	VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT	Jun 22, 1988	Substantially Equivalent	HDC CORP.
K874874	ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP	Feb 18, 1988	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K875269	ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE	Feb 12, 1988	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K874751	TRACKER-25 INFUSION CATHETER	Feb 12, 1988	Substantially Equivalent	TARGET THERAPEUTICS
K873485	EDSLAB (R) OCCLUSION BALLOON CATHETER	Dec 03, 1987	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K872182	POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE	Oct 30, 1987	Substantially Equivalent	POLYSTAN C/O VITALCOR, INC.
K872163	IMPRA DUAL LUMEN SUBCLAVIAN CATHETER	Oct 30, 1987	Substantially Equivalent	IMPRA, INC.
K873035	VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER	Sep 25, 1987	Substantially Equivalent	GISH BIOMEDICAL, INC.
K871573	CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS	Sep 16, 1987	Substantially Equivalent	SPECTRAMED, INC.
K871080	PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER	Aug 12, 1987	Substantially Equivalent	CATHETER TECHNOLOGY CORP.
K863791	SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX	Jun 25, 1987	Substantially Equivalent	GISH BIOMEDICAL, INC.
K863790	J-CATH, GISH MODEL NO. JVAC-XXXX	Jun 24, 1987	Substantially Equivalent	GISH BIOMEDICAL, INC.
K870411	CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.	Jun 02, 1987	Substantially Equivalent	MEDICAL SURGICAL CONCEPTS, INC.
K870412	TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT	May 27, 1987	Substantially Equivalent	MEDICAL SURGICAL CONCEPTS, INC.
K871425	ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER	May 22, 1987	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K865074	CORDAY CORONARY SINUS INFUSION CATHETER	May 06, 1987	Substantially Equivalent	RETROPERFUSION SYSTEMS, INC.
K870067	MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20	Apr 28, 1987	Substantially Equivalent	VYGON CORP.
K870075	CENTRAL VENOUS CATHETER	Apr 27, 1987	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K870675	ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY	Apr 09, 1987	Substantially Equivalent	QUINTON, INC.
K864118	MEDI-TECH SELECTIVE TORQUE CATHETER	Apr 09, 1987	Substantially Equivalent	MEDI-TECH, INC.
K863916	CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM	Jan 06, 1987	Substantially Equivalent	CARDIO-VASCULAR INNOVATIONS, INC.
K863684	URESIL SUBCLAVIAN CATHETER	Jan 06, 1987	Substantially Equivalent	URESIL CORP.
K862724	VEIN VALVE CUTTER	Jan 02, 1987	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K863564	URESIL IRRIGATION CATHETER	Oct 10, 1986	Substantially Equivalent	URESIL CORP.
K862117	TRACKER INFUSION CATHETER	Oct 01, 1986	Substantially Equivalent	TARGET THERAPEUTICS
K862975	MODIFIED PTCA GUIDING CATHETERS	Sep 23, 1986	Substantially Equivalent	CORDIS CORP.
K863322	MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS	Sep 19, 1986	Substantially Equivalent	QUINTON, INC.
K862056	[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP	Aug 25, 1986	Substantially Equivalent	ARROW INTL., INC.
K861827	CURITY CENTRAL VENOUS CATHETERIZATION TRAY	Jul 11, 1986	Substantially Equivalent	THE KENDAL CO.
K861829	CURITY CENTRAL VENOUS CATHETER	Jul 10, 1986	Substantially Equivalent	THE KENDAL CO.
K861828	CURITY VENOUS CATHETERIZATION KIT	Jul 10, 1986	Substantially Equivalent	THE KENDAL CO.
K854610	VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER	May 08, 1986	Substantially Equivalent	GISH BIOMEDICAL, INC.
K861165	PHARMASEAL DUAL LUMEN CATHETER	May 05, 1986	Substantially Equivalent	AMERICAN PHARMASEAL DIV. AHSC
K861008	PERCUTANEOUS CATHETERS	Apr 29, 1986	Substantially Equivalent	MICOR, INC.
K855201	BARD PARKER PERFUSION CATHETER	Apr 29, 1986	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K860699	RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES	Apr 02, 1986	Substantially Equivalent	INTRACATH, INC.
K860339	PERCUTANEOUS CATHETERS	Mar 31, 1986	Substantially Equivalent	MICOR, INC.
K854984	CUP MONITORING KIT CVPK-14	Mar 31, 1986	Substantially Equivalent	MEDICAL COMPONENTS, INC.
K851241	GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO	Feb 26, 1986	Substantially Equivalent	COOK, INC.
K853714	PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA	Jan 13, 1986	Substantially Equivalent	AMERICAN PHARMASEAL DIV. AHSC
K854137	ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC	Dec 03, 1985	Substantially Equivalent	ARROW INTL., INC.
K853998	GUIDING CATHETER	Nov 06, 1985	Substantially Equivalent	TARGET THERAPEUTICS
K854000	INFUSION CATHETER W/SIDE HOLES	Nov 05, 1985	Substantially Equivalent	TARGET THERAPEUTICS
K853997	INFUSION CATHETER	Nov 05, 1985	Substantially Equivalent	TARGET THERAPEUTICS
K852791	7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS	Nov 05, 1985	Substantially Equivalent	CARDIO-VASCULAR INNOVATIONS, INC.
K853860	REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE	Oct 18, 1985	Substantially Equivalent	QUINTON, INC.
K852914	ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION	Sep 25, 1985	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K852491	AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER	Sep 25, 1985	Substantially Equivalent	AMERICAN PHARMASEAL DIV. AHSC
K852815	TRIPLE LUMEN RIGHT ATRIAL CATHETER	Aug 26, 1985	Substantially Equivalent	QUINTON, INC.
K852388	MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT	Aug 22, 1985	Unknown	QUINTON, INC.
K852099	BARD-PARKER IRRIGATION CATHETER	Aug 09, 1985	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K850829	WIRE, GUIDE, CATHETER	Jun 26, 1985	Substantially Equivalent	LAKE REGION MFG., INC.
K850353	CORONARY INFUSION CATHETER W/SIDEHOLES	Apr 10, 1985	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K843263	ARROW-JOHANS ECG ADAPTOR	Sep 20, 1984	Substantially Equivalent	ARROW INTL., INC.
K842645	CARDIAC SUPPLY TRAY	Aug 27, 1984	Substantially Equivalent	DEROYAL INDUSTRIES, INC.
K841797	MULTIPRO CATHETER	Aug 10, 1984	Substantially Equivalent	SHILEY, INC.
K842084	AXIOM FEMORAL VENUS CATHETER	Aug 01, 1984	Substantially Equivalent	AXIOM MEDICAL, INC.
K842316	CRITIKON TRIPLE-LUMEN CENTRAL VENOUS	Jul 20, 1984	Substantially Equivalent	CRITIKON COMPANY,LLC
K842176	RAAF DUAL LUMEN CATHETER	Jul 13, 1984	Substantially Equivalent	QUINTON, INC.
K841828	CENTRAL VENOUS CATHETER W/BIG-GARD	Jul 13, 1984	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K840762	SILVERTORQUE CEREBRAL CATHETER	Jul 13, 1984	Substantially Equivalent	SURGIMED CORP.
K841587	CENTRAL VENOUS ACCESS CATHETER CVAC-XX	Jun 13, 1984	Substantially Equivalent	GISH BIOMEDICAL, INC.
K840761	SILVERTORQUE VISCERAL CATHETER	Jun 11, 1984	Substantially Equivalent	SURGIMED CORP.
K833873	CARDIOSEARCH RIGHT ATRIAL CATH-	Jun 11, 1984	Substantially Equivalent	CARDIO SEARCH, INC.
K834232	VAS-CATH DSA CATHETER/TRAY	Apr 24, 1984	Substantially Equivalent	VAS-CATH OF CANADA LTD.
K840240	MICROFUSE INTRAVENOUS CATHETER SET	Apr 17, 1984	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K833801	RIGHT CORONARY GUIDING CATHETER	Mar 12, 1984	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K840336	RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI	Feb 17, 1984	Substantially Equivalent	ARROW INTL., INC.
K840175	DOUBLE LUMEN INFUSION CATHETERS	Feb 10, 1984	Substantially Equivalent	MEDICAL COMPONENTS, INC.
K834109	MAHURKAR DUAL LIMEN FEMORAL CATHETER	Feb 04, 1984	Substantially Equivalent	QUINTON, INC.
K833573	CENTRAL VEIN CATH. TRAY CC-20-1420	Jan 11, 1984	Substantially Equivalent	INTERMED, INC.
K833825	MULTI-LUMEN INTRAVENOUS INFUSION CATH	Jan 10, 1984	Substantially Equivalent	MEDICAL PARAMETERS, INC.
K833433	PHYSIO-PROBE-HIGH PERMEABILITY CATH.	Dec 29, 1983	Substantially Equivalent	RESEARCH INDUSTRIES CORP.
K833303	DUOFLO 6F	Dec 27, 1983	Substantially Equivalent	ARGON MEDICAL CORP.
K832784	ULTRA LIGHT RAAF CATHETER	Oct 20, 1983	Substantially Equivalent	QUINTON, INC.
K831636	PERCUTANEOUS INTRODUCER KIT	Aug 24, 1983	Substantially Equivalent	ACCU-LINE
K832178	AMPLATZ HEPARIN COATED CATHETER	Aug 12, 1983	Substantially Equivalent	COOK, INC.
K832064	VENOUS CATHETER	Aug 08, 1983	Substantially Equivalent	CARDIO SEARCH, INC.
K831807	CATHETER INSERTION TRAYS, VARIOUS #'S	Jul 18, 1983	Substantially Equivalent	AMERICAN PHARMASEAL DIV. AHSC
K831729	PERCUTANEOUS CATHETER INSERTION TRAY	Jul 18, 1983	Substantially Equivalent	AMERICAN PHARMASEAL DIV. AHSC
K831717	CORONARY INFUSION CATHETER	Jun 30, 1983	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K831563	CORONARY GUIDING CATHETER-MODIFIED	Jun 30, 1983	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K822393	INTRAOPERATIVE BALLOON DILATION CATH.	Nov 01, 1982	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K821189	MULTIPURPOSE CATHETER	Jul 08, 1982	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K821480	RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT	Jun 17, 1982	Substantially Equivalent	THE HEALTHCARE GROUP LABORATORIES, INC.
K820736	CENTRAL VENOUS ACCESS CATHETER	Apr 15, 1982	Substantially Equivalent	HEMED, INC.
K820516	ARTERIAL CANALIZATION DEVICE	Apr 15, 1982	Substantially Equivalent	ALIMED, INC.
K820648	ARROW M.I.S. MULTI-LUMEN CATHETERIZA	Apr 14, 1982	Substantially Equivalent	ARROW INTL., INC.
K820009	ARROW JUGULAR PUNCTURE KIT 16 GA.	Jan 22, 1982	Substantially Equivalent	ARROW INTL., INC.
K813514	EDSLAB CATHETER COVER	Dec 29, 1981	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K811971	CORDIS DUCOR PTR SYSTEM	Aug 13, 1981	Substantially Equivalent	CORDIS CORP.
K810962	ARROW VESSEL CATHETER. KIT W/20GA INDWEL	Apr 29, 1981	Substantially Equivalent	ARROW INTL., INC.
K810461	BURRON CENTRAL VEIN CATHERIZATION KIT	Mar 11, 1981	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K810460	BURRON PERCUTANEOUS INDUCER SET	Mar 11, 1981	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K802287	RIGHT ATRIAL LINE KIT	Nov 20, 1980	Substantially Equivalent	STANCO MEDICAL, INC.
K790083	CATHETER, ARTERIAL LINE	Jan 25, 1979	Substantially Equivalent	NAMIC

FEI Numbers

This FDA classification entry is associated with 271 FEI numbers. Click on an entry to view related FDA registrations.

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1000121056: 328 registrations

1000123180: 115 registrations

1000136269: 265 registrations

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1000306139: 80 registrations

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1000512168: 447 registrations

1000518731: 132 registrations

1000563940: 52 registrations

1016427: 97 registrations

1018233: 409 registrations

1018470: 468 registrations

1028232: 48 registrations

1048735: 291 registrations

1118880: 21 registrations

1219930: 292 registrations

1220452: 34 registrations

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1313046: 64 registrations

1318694: 28 registrations

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1526534: 933 registrations

1526863: 66 registrations

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3010291427: 90 registrations

3010421104: 31 registrations

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3012179728: 109 registrations

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3014644549: 7 registrations

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3015550451: 87 registrations

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