Product Code: DQX FDA class 2 21 CFR 870.1330

Wire, Guide, Catheter

Cardiovascular

The Catheter Guide Wire is a flexible cardiovascular device used to navigate catheters through blood vessels to their intended target site during diagnostic or interventional procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQX and it is regulated under 21 CFR 870.1330 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

764

FEI Numbers

257

Registration Numbers

258

Unique Applicants

213

Years Active

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Basic Information

Product Code: DQX
Device Class: FDA class 2
Regulation Number: 870.1330
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 764 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254137	InQwire Amplatz Guide Wire	May 22, 2026	Substantially Equivalent	Merit Medical Ireland, Ltd.
K260544	FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40	Mar 20, 2026	Substantially Equivalent	FMD Co., Ltd.
K253746	Enroute 0.014'' Transcarotid Guidewire	Mar 19, 2026	Substantially Equivalent	Lake Region Medical
K253262	EmeryGlide (EG18008901)	Mar 06, 2026	Substantially Equivalent	Nano4imaging GmbH
K253847	Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)	Jan 31, 2026	Substantially Equivalent	Merit Medical Ireland, Ltd.
K251385	InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)	Jan 21, 2026	Substantially Equivalent	Merit Medical Ireland, Ltd.
K252674	Solo Pace Fusion System (SOLOFUSE1)	Jan 09, 2026	Substantially Equivalent	Solo Pace, Inc.
K251596	Lunderquist Extra Stiff Wire Guide	Nov 09, 2025	Substantially Equivalent	William Cook Europe Aps
K250203	SureAx-Guide	Oct 17, 2025	Substantially Equivalent	Sureax Medical, LLC
K250031	Amplatzer Guidewire	Oct 03, 2025	Substantially Equivalent	ABBOTT MEDICAL
K251181	Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)	Aug 29, 2025	Substantially Equivalent	Merit Medical Ireland, Ltd.
K250552	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire	Jul 25, 2025	Substantially Equivalent	ABBOTT MEDICAL
K250075	Medtronic Stedi Extra Support Guidewire	Jun 13, 2025	Substantially Equivalent	Medtronic, Inc.
K243733	SION blue PLUS	Apr 02, 2025	Substantially Equivalent	Asahi Intecc Co., Ltd.
K241962	Crossloop	Mar 27, 2025	Substantially Equivalent	Asahi Intecc Co., Ltd.
K242597	CROSSLEAD 0.018inch	Mar 05, 2025	Substantially Equivalent	Asahi Intecc Co., Ltd.
K241702	CROSSLEAD 0.014inch	Feb 06, 2025	Substantially Equivalent	Asahi Intecc Co., Ltd.
K241521	Prelude Small O.D. Introducer Guide Wire	Dec 10, 2024	Substantially Equivalent	Merit Medical Systems, Inc.
K242824	PTFE Guidewire	Dec 06, 2024	Substantially Equivalent	Lake Region Medical
K240818	R2P Radifocus Glidewire Advantage	Nov 26, 2024	Substantially Equivalent	Terumo Corporation
K240997	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire	Nov 06, 2024	Substantially Equivalent	ABBOTT MEDICAL
K241784	Arrow® Nitinol Wire	Sep 18, 2024	Substantially Equivalent	Teleflex Medical
K240859	Glidewire GT-R	Aug 21, 2024	Substantially Equivalent	Terumo Corporation
K241510	CROSSLEAD Tracker	Aug 14, 2024	Substantially Equivalent	Asahi Intecc Co., Ltd.
K240387	MINAMO blue; MINAMO viola	Jun 21, 2024	Substantially Equivalent	Asahi Intecc Co., Ltd.
K240460	FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)	Jun 13, 2024	Substantially Equivalent	FMD Co., Ltd.
K240864	PacePro Wire	May 24, 2024	Substantially Equivalent	Opsens, Inc.
K232662	BNLE Hydrophilic Jacketed Peripheral Guidewire	May 14, 2024	Substantially Equivalent	Biomerics Nle
K230418	Mighty Wire Guide Wire	Oct 28, 2023	Substantially Equivalent	Merit Medical Systems, Inc.
K232570	Steerant Super Stiff Guidewire	Oct 24, 2023	Substantially Equivalent	Medtronic Vascular
K232578	VASSALLO GT 018 G12; VASSALLO GT 018 G30	Oct 11, 2023	Substantially Equivalent	Filmec Co. , Ltd.
K232574	VASSALLO GT Crossing14	Oct 11, 2023	Substantially Equivalent	Filmec Co. , Ltd.
K230377	CROSSLEAD Penetration Peripheral Guide Wire	Jul 20, 2023	Substantially Equivalent	Asahi Intecc Co., Ltd.
K223791	TalWire	Jul 14, 2023	Substantially Equivalent	Embrace Medical , Ltd.
K230637	Wattson temporary pacing guidewire (2250)	May 05, 2023	Substantially Equivalent	Vascular Solutions, LLC
K221390	BNLE Access Guidewire	Apr 28, 2023	Substantially Equivalent	Biomerics Nle
K223432	Vassallo GT 018 Hybrid	Mar 09, 2023	Substantially Equivalent	Filmecc Co., Ltd.
K213898	ProTrack Pigtail Wire	Mar 01, 2023	Substantially Equivalent	Baylis Medical Company, Inc.
K221351	Mechanical Guidewire	Dec 19, 2022	Substantially Equivalent	Baylis Medical Company, Inc.
K222631	VASSALLO GT EXT	Oct 26, 2022	Substantially Equivalent	Filmecc Co., Ltd.
K221575	Pre-Formed Blue	Oct 07, 2022	Substantially Equivalent	Lake Region Medical
K212615	EpiFaith CV	Sep 21, 2022	Substantially Equivalent	Flat Medical Co., Ltd.
K213854	SavvyWire	Sep 14, 2022	Substantially Equivalent	Opsens, Inc.
K213868	ASAHI Gladius Mongo18 PV ES	Sep 06, 2022	Substantially Equivalent	Asahi Intecc Co., Ltd.
K221917	Stent Positioning Assistance System (SPAS)	Aug 19, 2022	Substantially Equivalent	Seven Sons , Ltd.
K213315	CROSSLEAD Peripheral Guide Wire	Jul 01, 2022	Substantially Equivalent	Asahi Intecc Co., Ltd.
K213949	VASSALLO GT 018 Floppy	Jun 30, 2022	Substantially Equivalent	Filmecc Co., Ltd.
K212268	FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT	May 27, 2022	Substantially Equivalent	FMD Co., Ltd.
K210548	Medline Integrated Arterial Catheter	May 17, 2022	Substantially Equivalent	Centurion Medical Products
K220075	Spartan Center Wire	Apr 19, 2022	Substantially Equivalent	Spartan Micro, Inc.
K213834	Cardio Flow Peripheral Guide Wire	Mar 18, 2022	Substantially Equivalent	Cardio Flow Inc.,
K220137	Lunderquist Extra Stiff Wire Guide	Feb 17, 2022	Substantially Equivalent	William Cook Europe Aps
K212167	R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire	Feb 09, 2022	Substantially Equivalent	Vascular Solutions, LLC
K211898	ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20	Dec 08, 2021	Substantially Equivalent	Asahi Intecc Co., Ltd.
K211741	Pre-Formed Extra Support Guidewire	Nov 22, 2021	Substantially Equivalent	Lake Region Medical
K203529	VASSALLO GT Hybrid	May 04, 2021	Substantially Equivalent	Filmecc Co., Ltd.
K203533	VASSALLO GT	Apr 21, 2021	Substantially Equivalent	Filmecc Co., Ltd.
K210235	Verrata PLUS Pressure Guide Wire	Apr 15, 2021	Substantially Equivalent	Volcano Corporation
K201720	LiPPS Analyzer, LiPPS Wire Pressure Guide Wire	Feb 18, 2021	Substantially Equivalent	Beijing Bywave Sensing Medical Technology Co., Ltd.
K201595	Merit Hydrophilic Guide Wire	Oct 14, 2020	Substantially Equivalent	Merit Medical Systems, Inc.
K202543	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	Sep 28, 2020	Substantially Equivalent	Volcano Corporation
K193653	Hydrophilic Coating Guide Wire	Aug 26, 2020	Substantially Equivalent	Suzhou Hengrui Disheng Medical Co., Ltd.
K201834	HI-TORQUE PROCEED Guide Wire Family	Jul 30, 2020	Substantially Equivalent	Abbott Vascular
K201760	Zoom 14 Guidewire	Jul 29, 2020	Substantially Equivalent	Scientia Vascular, LLC
K201690	Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire	Jul 21, 2020	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K200120	LiteSaber Wire Torque Assist Device	May 07, 2020	Substantially Equivalent	Vesatek, LLC
K200144	HI-TORQUE Steelcore Bare Guide Wire	Apr 08, 2020	Substantially Equivalent	Abbott Vascular
K193571	Go2Wire Guide Wire	Apr 08, 2020	Substantially Equivalent	Merit Medical System, Inc.
K192886	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	Mar 26, 2020	Substantially Equivalent	Volcano Corporation
K193548	Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire	Jan 18, 2020	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K192454	Wattson Temporary Pacing Guidewire	Jan 15, 2020	Substantially Equivalent	Vascular Solutions
K192599	ASAHI PTCA Guide Wire ASAHI Gaia Next	Jan 02, 2020	Substantially Equivalent	Asahi Intecc Co., Ltd.
K191907	OptoWire III	Jan 02, 2020	Substantially Equivalent	Opsens, Inc.
K193194	CrossTorq 14 Guidewire	Dec 13, 2019	Substantially Equivalent	Scientia Cardio Access, LLC
K193126	HI-TORQUE InfilTrac Guide Wire Family	Dec 11, 2019	Substantially Equivalent	Abbott Vascular
K191502	Heraeus Peripheral Guidewire	Nov 26, 2019	Substantially Equivalent	Heraeus Medical Components, LLC
K191464	Asahi PTCA Guide Wire Asahi SION Series	Nov 21, 2019	Substantially Equivalent	Asahi Intecc Co., Ltd.
K192783	Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile	Oct 30, 2019	Substantially Equivalent	Scientia Vascular, LLC
K191687	pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire	Oct 09, 2019	Substantially Equivalent	Phenox Limited
K190176	MINAMO	Aug 01, 2019	Substantially Equivalent	Asahi Intecc Co., Ltd.
K182985	Roadrunner PC Wire Guide, Olcott Torque Device	Jul 22, 2019	Substantially Equivalent	Cook Incorporated
K183062	ASAHI Silverway	Jul 01, 2019	Substantially Equivalent	Asahi Intecc Co., Ltd.
K182457	Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J	Apr 18, 2019	Substantially Equivalent	Brivant Limited (Lake Region Medical)
K182553	Inno-Pathwire	Mar 11, 2019	Substantially Equivalent	Suzhou Innomed Medical Device Co., Ltd.
K181353	Lunderquist® Fixed Core Wire Guide	Feb 15, 2019	Substantially Equivalent	Cook Incorporated
K183467	Roadrunner Extra Support Wire Guide	Jan 11, 2019	Substantially Equivalent	Cook Incorporated
K180830	Reuter Tip Deflecting Wire Guide	Dec 20, 2018	Substantially Equivalent	Cook Incorporated
K182315	Magic Torque DLVR Guidewire	Sep 26, 2018	Substantially Equivalent	Boston Scientific Corporation
K181647	Bandit guidewire	Jul 20, 2018	Substantially Equivalent	Vascular Solutions, Inc.
K180784	ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES	Jul 18, 2018	Substantially Equivalent	Asahi Intecc Co., Ltd.
K173277	ASAHI PTCA Guide Wire ASAHI SION black	Jul 05, 2018	Substantially Equivalent	Asahi Intecc Co., Ltd.
K180726	Savion DLVR Guidewire, Savion FLX Guidewire	Jun 18, 2018	Substantially Equivalent	Boston Scientific, Inc.
K181351	Double Flexible Tipped Wire Guides	Jun 14, 2018	Substantially Equivalent	Cook Incorporated
K181001	Medtronic Confida Brecker Guidewire	May 03, 2018	Substantially Equivalent	Medtronic Core Valve, LLC
K180795	JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire	Apr 12, 2018	Substantially Equivalent	Boston Scientific
K172187	Inno-Hydrowire	Apr 11, 2018	Substantially Equivalent	Suzhou Innomed Medical Device Co., Ltd.
K171997	Mandril Wire Guide	Mar 30, 2018	Substantially Equivalent	Cook Incorporated
K171912	Double Flexible Tip Wire Guides	Mar 19, 2018	Substantially Equivalent	Cook Incorporated
K171764	Fixed Core Wire Guides	Mar 09, 2018	Substantially Equivalent	Cook Incorporated
K180128	Warrior 14 guidewire	Feb 16, 2018	Substantially Equivalent	Vascular Solutions, Inc.
K171933	ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter	Feb 12, 2018	Substantially Equivalent	Asahi Intecc Co., Ltd.
K173235	Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile	Jan 22, 2018	Substantially Equivalent	Scientia Vascular, LLC
K173795	HI-TORQUE TurnTrac Guide Wire Family	Jan 12, 2018	Substantially Equivalent	Abbott Vascular
K171445	Amplatz Support Wire Guide with Apex Curve	Jan 10, 2018	Substantially Equivalent	Cook Incorporated
K171948	Roadrunner Extra Support Wire Guide	Jan 05, 2018	Substantially Equivalent	Cook Incorporated
K173532	Raider Guidewire	Dec 15, 2017	Substantially Equivalent	Vascular Solutions, Inc.
K171513	Lunderquist Extra Stiff Wire Guide	Dec 07, 2017	Substantially Equivalent	William Cook Europe Aps
K170915	TXM Hydrophilic Guidewire	Nov 21, 2017	Substantially Equivalent	Texasmedical Technologies, Inc.
K173423	MR Wire Guide Wire Straight, MR Wire Guide Wire Angled	Nov 17, 2017	Substantially Equivalent	Nano4imaging GmbH
K172453	WATCHDOG Hemostasis Valve Kit	Nov 09, 2017	Substantially Equivalent	Boston Scientific Corporation
K173052	Heraeus TMW Guidewire	Oct 20, 2017	Substantially Equivalent	Heraeus Medical Components, LLC
K170417	Glidewire GT	Sep 15, 2017	Substantially Equivalent	Terumo Corporation
K172073	Hi-Torque Command 18 Guide Wire	Aug 25, 2017	Substantially Equivalent	Abbott Vascular
K171897	Approach CTO Microwire Guide	Aug 21, 2017	Substantially Equivalent	Cook Incorporated
K170532	True Form Reshapable Guide Wire	Jul 21, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K170684	Firebow Wire Torque Assist Device	Jun 29, 2017	Substantially Equivalent	Vesatek, LLC
K170933	Merit Hydrophilic Guide Wire	Jun 22, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K170700	Inqwire Diagnostic Guide Wire	Apr 06, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K163426	ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension	Apr 03, 2017	Substantially Equivalent	Asahi Intecc Co., Ltd.
K170636	Fathom-16 Steerable Guidewires	Mar 22, 2017	Substantially Equivalent	Boston Scientific Corporation
K163575	Inqwire Diagnostic Guide Wire	Mar 03, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K163004	Radifocus Glidewire Advantage Track	Jan 30, 2017	Substantially Equivalent	Ashitaka Factory of Terumo Coporation
K162842	ASAHI PTCA Guide Wire ASAHI SUOH 03	Jan 27, 2017	Substantially Equivalent	Asahi Intecc Co., Ltd.
K163444	Spectre guidewire	Jan 06, 2017	Substantially Equivalent	Vascular Solutions, Inc.
K160785	Worker Guidewire	Dec 08, 2016	Substantially Equivalent	Argon Medical Devices, Inc.
K161702	Endura guidewire	Dec 06, 2016	Substantially Equivalent	Vascular Solutions, Inc.
K160594	MRWire Guide Wire	Nov 22, 2016	Substantially Equivalent	Nano4imaging GmbH
K160643	ENROUTE 0.014 Guidewire	Oct 18, 2016	Substantially Equivalent	Lake Region Medical
K153685	Sunmed Haemostatic Valves	Oct 13, 2016	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.
K161584	ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16	Oct 06, 2016	Substantially Equivalent	Asahi Intecc Co., Ltd.
K161887	Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip	Sep 20, 2016	Substantially Equivalent	Volcano Corporation
K153397	S-Wire Guidewire System	Aug 18, 2016	Substantially Equivalent	Concert Medical, LLC
K153106	ASAHI Fielder XT-A, ASAHI Fielder XT-R	Jun 21, 2016	Substantially Equivalent	Asahi Intecc Co., Ltd.
K160018	Arrow Quickflash Arterial Catheterization Device	Jun 13, 2016	Substantially Equivalent	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
K153443	ASAHI Astato XS 40	Feb 25, 2016	Substantially Equivalent	Asahi Intecc Co., Ltd.
K152231	Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire	Feb 12, 2016	Substantially Equivalent	Boston Scientific Corporation
K152991	OptoWire Deux	Feb 11, 2016	Substantially Equivalent	Opsens
K152497	PW Guidewires	Jan 22, 2016	Substantially Equivalent	Tatara Vascular, LLC
K151840	Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire	Dec 16, 2015	Substantially Equivalent	Boston Scientific Corporation
K151234	R350 guidewire	Nov 18, 2015	Substantially Equivalent	Vascular Solutions, Inc.
K152740	Radifocus Glidewire	Nov 16, 2015	Substantially Equivalent	Ashitaka Factory of Terumo Corp.
K152709	HI-TORQUE BALANCE	Oct 21, 2015	Substantially Equivalent	Abbott Vascular
K152404	Hi-Torque Command 18 Guide Wire	Sep 21, 2015	Substantially Equivalent	Abbott Vascular
K150465	Medtronic Confida Brecker Guidewire	Aug 03, 2015	Substantially Equivalent	Medtronic Core Valve, LLC
K150445	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	Jun 30, 2015	Substantially Equivalent	Asahi Intecc Co., Ltd.
K142598	Opto Wire and OptoMonitor System	Jun 12, 2015	Substantially Equivalent	Opsens, Inc.
K151244	Pre-Formed Guidewire	Jun 11, 2015	Substantially Equivalent	Lake Region Medical
K150802	Heavy Double Flexible Tipped Wire Guide	May 28, 2015	Substantially Equivalent	Cook Incorporated
K143252	Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)	Apr 23, 2015	Substantially Equivalent	Needle Tech Products, Inc.
K143316	Attain Hybrid Guide Wire	Mar 11, 2015	Substantially Equivalent	Medtronic, Inc.
K143135	Spring Coil Guidewire	Feb 20, 2015	Substantially Equivalent	Neometrics, Inc.
K141707	ULTRASKIN HYDROPHILIC GUIDE WIRE	Jan 21, 2015	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.
K143587	ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire	Jan 15, 2015	Substantially Equivalent	Boston Scientific Corporation
K142415	Hi-Torque JET Guide Wire Family	Dec 19, 2014	Substantially Equivalent	Abbott Vascular, Inc.
K141218	ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM	Dec 18, 2014	Substantially Equivalent	Vadiswire Corporation
K142051	PRELUDE PLASTIC JACKETED GUIDE WIRE	Dec 17, 2014	Substantially Equivalent	Merit Medical Systems, Inc.
K140536	HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE	Dec 17, 2014	Substantially Equivalent	Lake Region Medical
K141295	MERIT HYDROPHILIC GUIDEWIRE	Dec 16, 2014	Substantially Equivalent	Merit Medical Systems, Inc.
K141054	DISTAL ACCESS TORQUE DEVICE	Dec 10, 2014	Substantially Equivalent	Distal Access, LLC
K142393	PREDICATE III GUIDEWIRE	Nov 25, 2014	Substantially Equivalent	Lake Region Medical
K142254	CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector	Nov 13, 2014	Substantially Equivalent	St Jude Medical
K141339	ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE	Oct 23, 2014	Substantially Equivalent	Asahi Intecc Co., Ltd.
K140608	MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE	Sep 12, 2014	Substantially Equivalent	Merit Medical Systems, Inc.
K141831	HYDRAVIEW GUIDEWIRE	Sep 04, 2014	Substantially Equivalent	Brivant Limited
K141782	HI-TORQUE VERSATURN GUIDE WIRE	Aug 07, 2014	Substantially Equivalent	Abbott Vascular
K140695	COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE	Jun 12, 2014	Substantially Equivalent	Medtronic, Inc.
K140673	INSERTION TOOL	Apr 16, 2014	Substantially Equivalent	Boston Scientific Corp
K133155	HYDROPHILIC COATED GUIDEWIRE	Apr 07, 2014	Substantially Equivalent	Lake Region Medical
K140485	MANDREL GUIDEWIRE	Mar 27, 2014	Substantially Equivalent	Lake Region Medical
K133865	ASAHI GAIA FIRST, SECOND, THIRD	Mar 18, 2014	Substantially Equivalent	Asahi Intecc Co., Ltd.
K133396	VDRIVE WITH V-SONO	Feb 06, 2014	Substantially Equivalent	Stereotaxis, Inc.
K132623	MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE	Dec 19, 2013	Substantially Equivalent	Medtronic
K133230	INQWIRE DIAGNOSTIC GUIDE WIRE	Dec 12, 2013	Substantially Equivalent	Merit Medical Systems, Inc.
K132545	MEDIVALVE ACWIRE	Nov 08, 2013	Substantially Equivalent	Medivalve , Ltd.
K123792	HORIZON XVU (FFR)	Aug 30, 2013	Substantially Equivalent	Mennen Medical , Ltd.
K130798	PRE-FORMED GUIDEWIRES	Aug 23, 2013	Substantially Equivalent	Lake Region Medical, Inc.
K131710	MERIT HYDROPHILIC GUIDE WIRE	Jul 29, 2013	Substantially Equivalent	Merit Medical Systems, Inc.
K122659	VDRIVE W/V-SONO	Jul 26, 2013	Substantially Equivalent	Stereotaxis, Inc.
K130766	ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE	Jul 17, 2013	Substantially Equivalent	Cook, Inc.
K131288	VERRATA PRESSURE GUIDE WIRE	Jun 21, 2013	Substantially Equivalent	Volcano Corporation
K130104	GUIDEWIRE, PURSUER SERIES	Jun 13, 2013	Substantially Equivalent	Oscor, Inc.
K130588	MERIT HYDROPHILIC GUIDE WIRE	Apr 05, 2013	Substantially Equivalent	Merit Medical Systems, Inc.
K122469	ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ	Mar 08, 2013	Substantially Equivalent	Asahi Intecc Co., Ltd.
K122468	ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO	Mar 08, 2013	Substantially Equivalent	Asahi Intecc Co., Ltd.
K124007	SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY	Mar 07, 2013	Substantially Equivalent	Micro Therapeutics, Inc. D/B/A: Ev3, Inc.
K122590	RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE	Mar 01, 2013	Substantially Equivalent	Terumo Medical Corporation
K123707	ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE	Feb 28, 2013	Substantially Equivalent	Cook, Inc.
K123067	PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY	Jan 29, 2013	Substantially Equivalent	Abbott Vascular, Inc.
K123609	MERIT HYDROPHILIC GUIDE WIRE	Jan 16, 2013	Substantially Equivalent	Merit Medical Systems, Inc.
K121398	CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)	Dec 13, 2012	Substantially Equivalent	Guidepath Medical, Inc.
K122573	HI-TORQUE COMMAND GUIDE WIRE FAMILY	Nov 20, 2012	Substantially Equivalent	Abbott Vascular, Inc.
K122795	STINGRAY GUIDEWIRES	Nov 08, 2012	Substantially Equivalent	Bridgepoint Medical
K123024	TORQUE DEVICE	Oct 26, 2012	Substantially Equivalent	Boston Scientific Corporation
K122856	CHARTER GUIDEWIRE	Oct 17, 2012	Substantially Equivalent	Brivant, Ltd.
K122089	OSTIAL PRO STENT POSITIONING SYSTEM	Sep 21, 2012	Substantially Equivalent	Merit Medical Systems, Inc.
K120644	MERIT HYDROPHILIC GUIDE WIRE	Sep 19, 2012	Substantially Equivalent	Merit Medical Systems, Inc.
K122506	SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS	Sep 17, 2012	Substantially Equivalent	Surefire Medical, Inc.
K121776	AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE	Aug 14, 2012	Substantially Equivalent	Codman & Shurtleff, Inc.
K113498	DISPOSABLE TORQUE DEVICE	Jul 20, 2012	Substantially Equivalent	Coeur, Inc.
K113162	SLIDEWIRETM(TRADEMARK PENDING)	Jul 20, 2012	Substantially Equivalent	Acme-Monaco Corp.
K121745	MANTARAY GUIDEWIRES	Jul 13, 2012	Substantially Equivalent	Bridgepoint Medical
K112674	NAVIS TORQUER	Jul 06, 2012	Substantially Equivalent	Navis Medical,Inc
K120119	SUNMED GUIDE WIRE	May 11, 2012	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.
K120298	CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE	May 08, 2012	Substantially Equivalent	St. Jude Medical, Cardiac Rhythm Management Divisi
K120863	WHOLEY GUIDE WIRE SYSTEM	Apr 19, 2012	Substantially Equivalent	Covidien, LLC
K120881	MANTARAY GUIDEWIRES	Apr 18, 2012	Substantially Equivalent	Bridgepoint Medical
K113454	14 WIRE STANDARD, 14 WIRE LS	Feb 24, 2012	Substantially Equivalent	Micro Therapeutics, Inc.
K120137	VICTORY GUIDEWIRE (32 MODELS)	Feb 14, 2012	Substantially Equivalent	Brivant, Ltd.
K113716	ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE	Feb 06, 2012	Substantially Equivalent	Asahi Intecc Co., Ltd.
K112957	HI-TORQUE POWERTURN	Nov 08, 2011	Substantially Equivalent	Abbott Vascular-Cardiac Therapies
K112381	HI TORQUE CONNECT GUIDEWIRE	Nov 03, 2011	Substantially Equivalent	Lake Region Medical
K112631	VSI GUIDEWIRE	Oct 27, 2011	Substantially Equivalent	Vascular Solutions, Inc.
K112745	V-14 CONTROL WIRE GUIDEWIRE	Oct 18, 2011	Substantially Equivalent	Boston Scientific Corporation
K101986	ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE	Sep 09, 2011	Substantially Equivalent	Asahi Intecc Co., Ltd.
K111288	ANCHORWIRE GUIDEWIRE	Aug 02, 2011	Substantially Equivalent	Lake Region Medical
K111395	PRIMEWIRE PRESTIGE PLUS	Aug 01, 2011	Substantially Equivalent	Volcano Corporation
K111498	FATHOM (TM) 14 STEERABLE GUIDEWIRE	Jun 30, 2011	Substantially Equivalent	Boston Scientific Corp
K111488	MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003	Jun 30, 2011	Substantially Equivalent	Bridgepoint Medical
K111485	FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX	Jun 30, 2011	Substantially Equivalent	Boston Scientific Corporation
K103377	CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283	May 18, 2011	Substantially Equivalent	Brivant, Ltd.
K110479	ACUITY WHISPER VIEW GUIDE WIRES	Apr 08, 2011	Substantially Equivalent	Boston Scientific Corp
K110553	ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE	Mar 18, 2011	Substantially Equivalent	Asahi Intecc USA, Inc.
K101985	ASAHI GUIDE WIRE EXTENSION 165CM	Mar 07, 2011	Substantially Equivalent	Asahi Intecc Co., Ltd.
K110241	ENDOLOGIX GUIDEWIRE	Feb 25, 2011	Substantially Equivalent	Techdevice Corporation
K110163	APPROACH PRO ST WIRE GUIDE	Feb 25, 2011	Substantially Equivalent	Cook Incorporated
K103101	HI-TORQUE BALANCE MIDDLEWEIGHT ELITE	Feb 10, 2011	Substantially Equivalent	Abbott Vascular-Cardiac Therapies
K110009	ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE	Feb 02, 2011	Substantially Equivalent	Cook, Inc.
K102818	MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE	Dec 03, 2010	Substantially Equivalent	Micrus Endovascular Corporation
K103057	ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE	Nov 19, 2010	Substantially Equivalent	Asahi Intecc Co., Ltd.
K094062	PERCU-PRO GUIDEWIRE	Sep 27, 2010	Substantially Equivalent	Cardiosolutions, Inc.
K101729	NEOWIRE PTA/PTCA GUIDEWIRE	Sep 23, 2010	Substantially Equivalent	Neometrics, Inc.
K100578	ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S	Sep 22, 2010	Substantially Equivalent	Asahi Intecc Co., Ltd.
K102211	CRUISER 18 GUIDEWIRE	Sep 03, 2010	Substantially Equivalent	Brivant, Ltd.
K101339	ARCHER SUPER STIFF GUIDEWIRES	Aug 31, 2010	Substantially Equivalent	Medtronic, Inc.
K101648	HI-TORQUE WINN GUIDE WIRE FAMILY	Jul 08, 2010	Substantially Equivalent	Abbott Vascular, Inc.
K101116	HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH	Jun 23, 2010	Substantially Equivalent	Abbott Vascular-Cardiac Therapies
K100425	HASKAL TORQUE DEVICE	Jun 17, 2010	Substantially Equivalent	Elcam Medical Acal
K101011	HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL	May 24, 2010	Substantially Equivalent	Abbott Vascular, Inc.
K100930	PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J	Apr 30, 2010	Substantially Equivalent	Volcano Corporation
K100093	VSI TORQUE DEVICE	Apr 30, 2010	Substantially Equivalent	Vascular Solutions, Inc.
K100710	ROLL-X GUIDEWIRE	Apr 28, 2010	Substantially Equivalent	St Jude Medical
K100470	GTX 12 GIDEWIRE	Apr 21, 2010	Substantially Equivalent	Medtronic, Inc.
K100351	NEUROSCOUT STEERABLE GUIDEWIRE	Mar 16, 2010	Substantially Equivalent	Codman & Shurtleff, Inc.
K092965	TRAILRUNNER GUIDEWIRES	Feb 26, 2010	Substantially Equivalent	Lake Region Mfg., Inc.
K093647	TRAXCESS DOCKING WIRE	Feb 24, 2010	Substantially Equivalent	MicroVention, Inc.
K093515	3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON	Feb 16, 2010	Substantially Equivalent	Brivant, Ltd.
K093822	DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY	Jan 28, 2010	Substantially Equivalent	Shepherd Scientific, Inc.
K093681	MERIDIAN GUIDEWIRE	Jan 26, 2010	Substantially Equivalent	Ev3 Neurovascular
K093397	TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE	Dec 17, 2009	Substantially Equivalent	MicroVention, Inc.
K091582	GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15	Dec 04, 2009	Substantially Equivalent	Medtronic Vascular
K092303	MERIT LAUREATE HYDROPHILIC GUIDE WIRE	Oct 27, 2009	Substantially Equivalent	Merit Medical Systems, Inc.
K091825	HI-TORQUE PROGRESS GUIDE WIRE FAMILY	Sep 25, 2009	Substantially Equivalent	Abbott Vascular, Inc.
K090193	CONDUCTOR CORONARY GUIDEWIRE	Sep 25, 2009	Substantially Equivalent	Concert Medical, LLC
K091385	APPROACH HYDRO ST WIRE GUIDE, MODEL HMW	Aug 07, 2009	Substantially Equivalent	Cook, Inc.
K083094	STREAMER POLYMER GUIDEWIRE	Jul 07, 2009	Substantially Equivalent	Brivant, Ltd.
K090554	ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE	Jul 02, 2009	Substantially Equivalent	Boston Scientific Corp
K081775	THE MEDCOMP .010 VASCULAR GUIDEWIRES	Mar 25, 2009	Substantially Equivalent	Medcomp
K083738	HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05	Mar 11, 2009	Substantially Equivalent	Abbott Vascular
K090274	MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE	Mar 03, 2009	Substantially Equivalent	Micrus Endovascular Corporation
K083732	TAD AND TAD II TAPERED GUIDE WIRES	Feb 25, 2009	Substantially Equivalent	Abbott Vascular
K083713	.035 LOC GUIDE WIRE EXTENSION	Feb 23, 2009	Substantially Equivalent	Abbott Vascular
K083727	STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012	Feb 20, 2009	Substantially Equivalent	Bridgepoint Medical
K083706	HI-TORQUE VERSACORE GUIDE WIRE	Feb 06, 2009	Substantially Equivalent	Abbott Vascular
K082873	MEDTRONIC ANGIOGRAPHIC GUIDE WIRES	Feb 06, 2009	Substantially Equivalent	Medtronic Vascular
K083904	ASAHI SUOH PTCA GUIDE WIRE	Jan 29, 2009	Substantially Equivalent	Asahi Intecc Co., Ltd.
K083145	ASAHI GUIDE WIRE EXTENSION, MODEL AG149000	Jan 12, 2009	Substantially Equivalent	Asahi Intecc Co., Ltd.
K082094	BARD PTFE (TEFLON) COATED GUIDE WIRES	Dec 17, 2008	Substantially Equivalent	C.R. Bard Inc., Bard Electrophysiology Division
K082922	FREEWAY AND RAILRUNNER GUIDEWIRES	Dec 09, 2008	Substantially Equivalent	Lake Region Mfg., Inc.
K082935	VISION WIRE CORONARY GUIDEWIRE	Dec 04, 2008	Substantially Equivalent	Biotronik, Inc.
K083146	ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000	Nov 21, 2008	Substantially Equivalent	Asahi Intecc Co., Ltd.
K081187	BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001	Oct 08, 2008	Substantially Equivalent	Bridgepoint Medical
K082304	ROLL-X GUIDEWIRE	Aug 27, 2008	Substantially Equivalent	St Jude Medical
K080637	POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS	Aug 12, 2008	Substantially Equivalent	Stereotaxis, Inc.
K080364	FINDRWIRZ GUIDE WIRE SYSTEM	Aug 11, 2008	Substantially Equivalent	Sentreheart, Inc.
K081337	APPROACH CTO WIRE GUIDE	Aug 08, 2008	Substantially Equivalent	Cook Incorporated
K081021	KINETIX GUIDEWIRE, PLUS GUIDEWIRE	Aug 08, 2008	Substantially Equivalent	Boston Scientific Corp
K080765	CROSSER LP SYSTEM	Jun 20, 2008	Substantially Equivalent	Flowcardia, Inc.
K080863	TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE	Apr 17, 2008	Substantially Equivalent	MicroVention, Inc.
K072460	HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE	Apr 11, 2008	Substantially Equivalent	Abbott Vascular, Inc.
K080563	RUNTHROUGH NS EXTENSION WIRE	Mar 20, 2008	Substantially Equivalent	Terumo Medical Corp.
K080144	MANDREL GUIDEWIRES OR M-WIRES	Feb 26, 2008	Substantially Equivalent	Lake Region Mfg., Inc.
K073162	SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING	Feb 08, 2008	Substantially Equivalent	Kensey Nash Corporation
K073655	PEGASUS STEERABLE (PTCA) GUIDEWIRE	Jan 28, 2008	Substantially Equivalent	Lake Region Mfg., Inc.
K073082	CPS COURIER GUIDEWIRE	Jan 09, 2008	Substantially Equivalent	Brivant, Ltd.
K070945	ASAHI PTCA GUIDE WIRE	Jan 09, 2008	Substantially Equivalent	Asahi Intecc Co., Ltd.
K072552	MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE	Dec 14, 2007	Substantially Equivalent	Merit Medical Systems, Inc.
K072705	ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J	Oct 23, 2007	Substantially Equivalent	Asahi Intecc Co., Ltd.
K070212	CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)	Oct 12, 2007	Substantially Equivalent	Ovalum , Ltd.
K072431	ASAHI PTCA GUIDE WIRE, X-TREME	Sep 26, 2007	Substantially Equivalent	Asahi Intecc Co., Ltd.
K071029	CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)	Aug 24, 2007	Substantially Equivalent	Stereotaxis, Inc.
K071721	ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371	Jul 13, 2007	Substantially Equivalent	Asahi Intecc Co., Ltd.
K062192	OSTIAL PRO STENT POSITIONING SYSTEM	May 24, 2007	Substantially Equivalent	Ostial Solutions, LLC
K070410	COOK MICROWIRE WIRE GUIDE	Apr 27, 2007	Substantially Equivalent	Cook, Inc.
K063695	RUNTHROUGH NS	Apr 27, 2007	Substantially Equivalent	Terumo Medical Corp.
K063210	ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488	Mar 15, 2007	Substantially Equivalent	Medtronic Inc. Cardiac Rhythm Management
K070150	VASCUPUNCTURE PICC GUIDEWIRE	Feb 15, 2007	Substantially Equivalent	Neometrics, Inc.
K063819	ASAHI PTCA GUIDE WIRE, FIELDER FC	Jan 26, 2007	Substantially Equivalent	Asahi Intecc Co., Ltd.
K063372	RADIFOCUS GLIDEWIRE ADVANTAGE	Jan 19, 2007	Substantially Equivalent	Terumo Medical Corp.
K061670	LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE	Jan 19, 2007	Substantially Equivalent	William Cook Europe Aps
K062186	ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J	Nov 09, 2006	Substantially Equivalent	Asahi Intecc Co., Ltd.
K061984	TREASURE	Oct 05, 2006	Substantially Equivalent	Asahi Intecc Co., Ltd.
K061453	HI-TORQUE WHISPER VIEW GUIDE WIRE	Jun 22, 2006	Substantially Equivalent	Guidant Corp.
K060551	BRIVANT GUIDEWIRE	Jun 07, 2006	Substantially Equivalent	Brivant Limited
K061171	SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX	Jun 02, 2006	Substantially Equivalent	Biosphere Medical, Inc.
K060449	HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE	May 30, 2006	Substantially Equivalent	Guidant Corporation
K053265	MICRUS GUIDE WIRE, WATUSI 0.014	Apr 28, 2006	Substantially Equivalent	Micrus Endovascular Corporation
K053187	AMPLATZER NOODLEWIRE GUIDEWIRE	Apr 27, 2006	Substantially Equivalent	Aga Medical Corp.
K060454	TITAN GUIDEWIRE	Mar 24, 2006	Substantially Equivalent	Lake Region Mfg., Inc.
K053268	PVS 2000 SYNCHRO2 GUIDEWIRE	Mar 13, 2006	Substantially Equivalent	Boston Scientific - Precision Vascular
K053251	TECHDEVICE GUIDEWIRE	Mar 08, 2006	Substantially Equivalent	Techdevice Corporation
K052347	TITAN STEERABLE (PTCA) GUIDEWIRE	Feb 17, 2006	Substantially Equivalent	Lake Region Mfg., Inc.
K052339	ASAHI PTCA GUIDE WIRE	Nov 30, 2005	Substantially Equivalent	Asahi Intecc Co., Ltd.
K052783	MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX	Oct 27, 2005	Substantially Equivalent	Boston Scientific Corp
K052022	ASAHI PTCA GUIDE WIRE FIELDER	Aug 25, 2005	Substantially Equivalent	Asahi Intecc Co., Ltd.
K051062	VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO	Jul 15, 2005	Substantially Equivalent	Flowcardia, Inc.
K051374	CARDIODRIVE CATHETER ADVANCEMENT SYSTEM	Jun 23, 2005	Substantially Equivalent	Stereotaxis, Inc.
K050964	PV 1900 SYNCHRO 0.016 GUIDEWIRE	Jun 13, 2005	Substantially Equivalent	Boston Scientific - Precision Vascular
K050915	SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]	Jun 07, 2005	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K050873	CANALIZER HYDROPHILIC GUIDE WIRE	May 26, 2005	Substantially Equivalent	Medical Device Technologies, Inc.
K050756	SKIPPER AND SKIPPER RACE GUIDEWIRE	May 05, 2005	Substantially Equivalent	Invatec Innovative Technologies, S.R.L.
K042373	GALEO FOCUS GUIDE WIRE	Mar 02, 2005	Substantially Equivalent	Biotronik, Inc.
K043398	MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE	Mar 01, 2005	Substantially Equivalent	Neometrics, Inc.
K043457	MODIFICATION TO ENDOVASCULAR GUIDE WIRE	Feb 28, 2005	Substantially Equivalent	Stereotaxis, Inc.
K042854	STEREOTAXIS ENDOVASCULAR GUIDE WIRE	Feb 08, 2005	Substantially Equivalent	Stereotaxis, Inc.
K043422	ASAHI PTCA GUIDE WIRE, J SHAPE SERIES	Jan 12, 2005	Substantially Equivalent	Asahi Intecc Co., Ltd.
K042370	TORAYGUIDE GUIDEWIRE	Dec 17, 2004	Substantially Equivalent	Toray Industries (America), Inc.
K040592	CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE	Dec 17, 2004	Substantially Equivalent	Cordis Corp.
K042996	COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE	Nov 24, 2004	Substantially Equivalent	Volcano Therapeutics, Inc.
K042264	GUIDEWIRES	Nov 24, 2004	Substantially Equivalent	Rocket Medical Plc
K042611	LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE	Nov 12, 2004	Substantially Equivalent	Cook, Inc.
K041740	SILICONE COATED GUIDEWIRE	Oct 15, 2004	Substantially Equivalent	Arrow International, Inc.
K042338	CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE	Sep 16, 2004	Substantially Equivalent	Lake Region Mfg., Inc.
K041973	MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM	Aug 16, 2004	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K041762	FINISHING WIRE SUPPORTRAK	Aug 06, 2004	Substantially Equivalent	Guidant Corporation
K041531	ASAHI PTCA GUIDE WIRE CONFIANZA PRO	Aug 03, 2004	Substantially Equivalent	Asahi Intecc Co., Ltd.
K041624	PTCA STEERABLE HYDROPHILIC GUIDEWIRE	Jul 16, 2004	Substantially Equivalent	Lake Region Mfg., Inc.
K040825	LAKE REGION HYDROPHILIC GUIDEWIRE	May 17, 2004	Substantially Equivalent	Lake Region Mfg., Inc.
K040867	PERIVAC KIT, MODELS 4304, 4305, 4314, 4315	Apr 30, 2004	Substantially Equivalent	Boston Scientific Corp
K040786	VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING	Apr 19, 2004	Substantially Equivalent	Neometrics, Inc.
K040037	MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM	Mar 03, 2004	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K040345	MODIFICATION TO NITREX NITINOL GUIDEWIRE	Mar 02, 2004	Substantially Equivalent	Ev3, Inc.
K040100	ARROW ECHOGENIC INTRODUCER NEEDLE	Mar 01, 2004	Substantially Equivalent	Arrow Intl., Inc.
K040140	IQ GUIDE WIRE	Feb 12, 2004	Substantially Equivalent	Boston Scientific Corp
K033929	MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM	Jan 12, 2004	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K033742	BOSTON SCIENTIFIC V-18 CONTROL WIRE	Jan 12, 2004	Substantially Equivalent	Boston Scientific Corp
K032031	SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM	Jan 07, 2004	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K033758	HYDROPHILIC GUIDEWIRE	Dec 19, 2003	Substantially Equivalent	Lake Region Mfg., Inc.
K033708	MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM	Dec 11, 2003	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K033542	EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE	Dec 05, 2003	Substantially Equivalent	Galt Medical Corp.
K033321	SELECTIVA SB GUIDEWIRE	Nov 05, 2003	Substantially Equivalent	Neometrics, Inc.
K032899	RADIUS COUGAR WIRE	Oct 17, 2003	Substantially Equivalent	Radius Medical Technologies, Inc.
K032411	JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE	Oct 07, 2003	Substantially Equivalent	Js Vascular, Inc.
K031652	VASCUPUNCTURE PICC GUIDEWIRE	Sep 30, 2003	Substantially Equivalent	Neometrics, Inc.
K032615	ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300	Sep 16, 2003	Substantially Equivalent	Asahi Intecc Co., Ltd.
K031678	HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	Aug 26, 2003	Substantially Equivalent	Guidant Corp.
K031442	PBN GUIDEWIRES	Aug 13, 2003	Substantially Equivalent	Medical Device Technologies, Inc.
K032146	PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES	Aug 12, 2003	Substantially Equivalent	Precision Vascular Systems, Inc.
K032050	PERIVAC KIT	Aug 08, 2003	Substantially Equivalent	Boston Scientific Corp
K032183	IQ HYDROPHILIC GUIDE WIRE	Aug 01, 2003	Substantially Equivalent	Boston Scientific Corp
K032129	RADIUS 018 COUGAR WIRE	Jul 17, 2003	Substantially Equivalent	Radius Medical Technologies, Inc.
K031916	GALT MEDICAL GUIDEWIRE	Jul 17, 2003	Substantially Equivalent	Galt Medical Corp.
K031864	NITREX NITINOL GUIDEWIRE	Jun 24, 2003	Substantially Equivalent	Ev3 Corporation
K030617	PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE	May 21, 2003	Substantially Equivalent	Boston Scientific Scimed, Inc.
K031277	JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002	May 14, 2003	Substantially Equivalent	Jomed, Inc.
K030549	HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG	May 14, 2003	Substantially Equivalent	Guidcorp
K022813	STEERABLE GUIDEWIRE	Feb 14, 2003	Substantially Equivalent	Lake Region Mfg., Inc.
K030019	MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE	Jan 24, 2003	Substantially Equivalent	Guidant Corp.
K024021	NITREX NITINOL GUIDEWIRE	Jan 24, 2003	Substantially Equivalent	Ev3 Corporation
K022762	JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050	Dec 16, 2002	Substantially Equivalent	Jomed, Inc.
K023700	PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE	Dec 04, 2002	Substantially Equivalent	Precision Vascular Systems, Inc.
K021363	ENDOVASCULAR GUIDE WIRE	Nov 27, 2002	Substantially Equivalent	Stereotaxis, Inc.
K023300	HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J	Oct 28, 2002	Substantially Equivalent	Guidant Corp.
K022357	TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815	Oct 16, 2002	Substantially Equivalent	Boston Scientific, Target
K021638	ILT ADVANCING MECHANISM, MODEL A115AMI	Jul 26, 2002	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K021990	GALT MEDICAL GUIDEWIRE	Jul 18, 2002	Substantially Equivalent	Galt Medical Corp.
K021243	ILT TORQUER, MODEL 114TR1	Jul 11, 2002	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K020821	SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117	Jun 03, 2002	Substantially Equivalent	Biotronik, Inc.
K021323	MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM	May 22, 2002	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K021219	SMARTWIRE/SMARTMAP PRESSURE SYSTEM	May 17, 2002	Substantially Equivalent	Jomed, Inc.
K021228	HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE	May 15, 2002	Substantially Equivalent	Guidant Corp.
K021285	HI-TORQUE EXTRA S'PORT GUIDEWIRE	May 02, 2002	Substantially Equivalent	Guidant Corp.
K011986	SAFE-STEER GUIDE WIRE SYSTEM	Apr 03, 2002	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K014075	BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145	Mar 07, 2002	Substantially Equivalent	Baylis Medical Co., Inc.
K020340	MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING	Mar 01, 2002	Substantially Equivalent	Guidant Corp.
K020283	BACK-UP MEIER STEERABLE GUIDEWIRE	Feb 11, 2002	Substantially Equivalent	Boston Scientific Corp
K012861	VASCUPUNCTURE ACCESS WIRE	Feb 05, 2002	Substantially Equivalent	Neometrics, Inc.
K012534	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	Jan 24, 2002	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K013833	HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096	Jan 16, 2002	Substantially Equivalent	Guidant Corp.
K013092	HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	Dec 13, 2001	Substantially Equivalent	Guidant Corp.
K013024	SELECTIVA GUIDEWIRE	Dec 04, 2001	Substantially Equivalent	Neometrics, Inc.
K011905	SNIPER ELITE MODEL-OR-E3872XX SERIES	Aug 28, 2001	Substantially Equivalent	Maxxim Medical
K011906	BACK-UP MEIER GUIDEWIRE	Aug 13, 2001	Substantially Equivalent	Boston Scientific Corp
K011968	STREERABLE PTCA GUIDEWIRE	Jul 25, 2001	Substantially Equivalent	Lake Region Mfg., Inc.
K011287	RADIUS COUGAR WIRE	May 25, 2001	Substantially Equivalent	Radius Medical Technologies, Inc.
K003084	CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012	May 16, 2001	Substantially Equivalent	Concentric Medical, Inc.
K011084	MANDREL GUIDEWIRE ASSEMBLY	May 10, 2001	Substantially Equivalent	Lake Region Mfg., Inc.
K010497	SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300	Mar 22, 2001	Substantially Equivalent	Micro Therapeutics, Inc.
K002907	PVS 1300 NEURO GUIDE WIRE	Mar 08, 2001	Substantially Equivalent	Precision Vascular Systems, Inc.
K010511	MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES	Mar 01, 2001	Substantially Equivalent	Cordis Neurovascular, Inc.
K003394	APPALEAD GW+03XXXXXXR SERIES	Jan 30, 2001	Substantially Equivalent	Nipro Medical Corp.
K003483	MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)	Dec 06, 2000	Substantially Equivalent	Lake Region Mfg., Inc.
K003398	WIRECLIP TORQUER	Dec 01, 2000	Substantially Equivalent	Boston Scientific Corporation Northwest Technology
K002707	PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING	Nov 08, 2000	Substantially Equivalent	Precision Vascular Systems, Inc.
K002962	PRESSURE WIRE SENSOR, MODEL 12003/12303	Oct 04, 2000	Substantially Equivalent	Radi Medical Systems AB
K002289	INQWIRE DIAGNOSTIC GUIDE WIRE	Oct 04, 2000	Substantially Equivalent	Merit Medical Systems, Inc.
K002346	WIRE, GUIDE, CATHETER, MODEL QSW1000	Sep 27, 2000	Substantially Equivalent	Medtronic Ave, Inc.
K002206	HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO	Aug 24, 2000	Substantially Equivalent	Guidant Corp.
K002212	MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608	Aug 03, 2000	Substantially Equivalent	Micro Therapeutics, Inc.
K001736	GALEO HYDRO AND GALEO HYDRO J-TIP	Aug 02, 2000	Substantially Equivalent	Biotronik, Inc.
K001251	SNIPER, MODEL OR-3872XX SERIES	Jul 07, 2000	Substantially Equivalent	Nipro Medical Corp.
K001454	SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D	Jun 07, 2000	Substantially Equivalent	Micro Therapeutics, Inc.
K001198	DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET	May 12, 2000	Substantially Equivalent	Datascope Corp.
K001033	AGILITY STEERABLE GUIDEWIRE	Apr 14, 2000	Substantially Equivalent	Cordis Neurovascular, Inc.
K000011	MODIFIED HYDROPHILIC COATED GUIDEWIRE	Mar 01, 2000	Substantially Equivalent	Lake Region Mfg., Inc.
K981936	ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION	Feb 16, 2000	Substantially Equivalent	Advanced Biomedical Devices, Inc.
K994358	ATW MARKER WIRE STEERABLE GUIDEWIRE	Jan 13, 2000	Substantially Equivalent	Cordis Corp.
K993000	BARD HYDROPHILIC COATED GUIDE WIRES	Nov 02, 1999	Substantially Equivalent	C.R. Bard, Inc.
K992169	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	Oct 28, 1999	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K993257	.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI	Oct 21, 1999	Substantially Equivalent	Micro Therapeutics, Inc.
K991646	AGILITY STEERABLE GUIDEWIRE	Sep 23, 1999	Substantially Equivalent	Cordis Neurovascular, Inc.
K992237	MEDTRONIC GT2 FUSION GUIDE WIRES	Sep 09, 1999	Substantially Equivalent	Medtronic Vascular
K990271	ENDOSONICS TRAK BACK DEVICE	Aug 30, 1999	Substantially Equivalent	Endosonics Corp.
K990823	PVS 1400 GUIDEWIRE	Jul 23, 1999	Substantially Equivalent	Precision Vascular Systems, Inc.
K991898	ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE	Jun 16, 1999	Substantially Equivalent	Microvena Corp.
K991194	MODIFICATION TO ULTRA-SELECT GUIDEWIRE	May 05, 1999	Substantially Equivalent	Microvena Corp.
K991152	HI-TORQUE BALANCE TREK GUIDE WIRE	Apr 29, 1999	Substantially Equivalent	Guidant Corp.
K990639	ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.	Mar 25, 1999	Substantially Equivalent	Guidant Corp.
K983346	STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF	Mar 23, 1999	Substantially Equivalent	Guidant Corp.
K984394	ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING	Mar 08, 1999	Substantially Equivalent	Guidant Corp.
K983506	PRESSUREWIRE SENSOR, MODEL #12001	Feb 03, 1999	Substantially Equivalent	Radi Medical Systems AB
K982559	GUIDEWIRE	Feb 01, 1999	Substantially Equivalent	Galt Medical Corp.
K982272	GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018	Jan 08, 1999	Substantially Equivalent	Biotronik, Inc.
K982543	SILVERSTREAK HYDROPHILIC GUIDEWIRE	Dec 11, 1998	Substantially Equivalent	Micro Therapeutics, Inc.
K983771	STRATEGY CORONARY WIRE GUIDE	Nov 12, 1998	Substantially Equivalent	Cook, Inc.
K974241	SCIMED INFORMER PRESSURE WIRE SYSTEM	Nov 12, 1998	Substantially Equivalent	Scimed Life Systems, Inc.
K983033	ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE	Nov 10, 1998	Substantially Equivalent	Guidant Corp.
K982876	HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282	Nov 10, 1998	Substantially Equivalent	Guidant Corp.
K980977	PIOLAX HYDROPHILIC GUIDEWIRE	Oct 27, 1998	Substantially Equivalent	Piolax Medical Devices, Inc.
K982592	DOCKING-EXTENSION WIRE	Oct 21, 1998	Substantially Equivalent	Schneider (Europe) GmbH
K974713	BARD HYDROPHILLIC COATED GUIDE WIRE	Oct 14, 1998	Substantially Equivalent	C.R. Bard, Inc.
K982083	ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	Sep 11, 1998	Substantially Equivalent	Guidant Corp.
K971322	CORE AND COIL ASSEMBLY GUIDEWIRE	Jul 22, 1998	Substantially Equivalent	Lake Region Mfg., Inc.
K981381	ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1	Jul 15, 1998	Substantially Equivalent	Guidant Corp.
K981326	LAKE REGION MANUFACTURING GUIDEWIRES	Jul 10, 1998	Substantially Equivalent	Lake Region Mfg., Inc.
K974560	CORDIS VANGUARD STEERABLE GUIDEWIRES	May 11, 1998	Substantially Equivalent	Cordis Corp.
K980360	SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES	Apr 29, 1998	Substantially Equivalent	Scimed Life Systems, Inc.
K980294	ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	Apr 24, 1998	Substantially Equivalent	Guidant Corp.
K972793	PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE	Apr 24, 1998	Substantially Equivalent	Radi Medical Systems AB
K980119	ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE	Mar 20, 1998	Substantially Equivalent	Guidant Corp.
K974773	HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC	Mar 13, 1998	Substantially Equivalent	Guidant Corp.
K973945	LUGE GUIDE WIRE	Jan 12, 1998	Substantially Equivalent	Scimed Life Systems, Inc.
K973845	CORDIS HYDRONOL STEERABLE GUIDEWIRE	Jan 05, 1998	Substantially Equivalent	Cordis Corp.
K973708	TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL	Dec 19, 1997	Substantially Equivalent	Merit Medical Systems, Inc.
K971086	RADIAL AND FEMORAL ARTERY CATHETER	Dec 19, 1997	Substantially Equivalent	B.Braun Medical, Inc.
K973494	HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG	Dec 12, 1997	Substantially Equivalent	Guidant Corp.
K971688	IVT 0.014 PTFE-COATED TRACKWIRE	Dec 11, 1997	Substantially Equivalent	Boston Scientific /International Technologies
K970938	HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING	Nov 17, 1997	Substantially Equivalent	Biocompatibles Cardiovascular, Inc.
K972944	MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT	Nov 03, 1997	Substantially Equivalent	Medtronics Interventional Vascular
K971719	THEROX INFUSION GUIDEWIRES	Nov 03, 1997	Substantially Equivalent	Therox, Inc.
K972762	CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES	Oct 14, 1997	Substantially Equivalent	Cardio Metrics, Inc.
K971281	RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE	Oct 09, 1997	Substantially Equivalent	Medcomp
K972290	ACS HI-TORQUE RULER GUIDE WIRE	Sep 17, 1997	Substantially Equivalent	Guidant Corp.
K972142	ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING	Aug 25, 1997	Substantially Equivalent	Guidant Corp.
K965140	CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM	Aug 18, 1997	Substantially Equivalent	Cardio Metrics, Inc.
K971395	GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE	Jul 14, 1997	Substantially Equivalent	Target Therapeutics
K971815	ASC BALANCE MIDDLEWEIGHT GUIDE WIRE	Jul 09, 1997	Substantially Equivalent	Guidant Corp.
K971254	TRANSEND EX PLATINUM GUIDEWIRE	Jul 01, 1997	Substantially Equivalent	Boston Scientific Corp
K970528	CLYDE CORONARY GUIDEWIRE	Jun 10, 1997	Substantially Equivalent	Schneider (Europe) GmbH
K970376	PTCA GUIDEWIRE	Jun 06, 1997	Substantially Equivalent	Lake Region Mfg., Inc.
K964551	CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID	May 21, 1997	Substantially Equivalent	Scimed Life Systems, Inc.
K970690	LOCKING STYLET 2	May 20, 1997	Substantially Equivalent	Cook Pacemaker Corp.
K970494	HANNIBAL GUIDEWIRE	May 09, 1997	Substantially Equivalent	Schneider (Europe) GmbH
K970244	SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES	Mar 28, 1997	Substantially Equivalent	Scimed Life Systems, Inc.
K965023	CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE	Mar 04, 1997	Substantially Equivalent	Scimed Life Systems, Inc.
K962765	CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)	Feb 21, 1997	Substantially Equivalent	Cordis Corp.
K964611	TRANSEND GUIDEWIRE	Jan 28, 1997	Substantially Equivalent	Boston Scientific Corp
K964352	TORQUE DEVICE	Jan 28, 1997	Substantially Equivalent	B.Braun Medical, Inc.
K963702	ACS HI-TORQUE IRON MAN GUIDE WIRE	Jan 22, 1997	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K962572	SCIMED CHOICE PT VISION PTCA GUIDE WIRE	Dec 17, 1996	Substantially Equivalent	Scimed Life Systems, Inc.
K954642	HYDRO-SELECT GUIDEWIRE	Dec 17, 1996	Substantially Equivalent	Microvena Corp.
K963320	TFX MEDICAL GUIDEWIRE	Dec 03, 1996	Substantially Equivalent	Tfx Medical Group
K961917	MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)	Nov 20, 1996	Substantially Equivalent	Medtronics Interventional Vascular
K963214	CORDIS ST STEERABLE GUIDEWIRE	Nov 13, 1996	Substantially Equivalent	Cordis Corp.
K963171	CINCH QR SGW EXTENSION	Nov 07, 1996	Substantially Equivalent	Cordis Corp.
K962932	CORDIS STABILIZER PLUS XS	Oct 25, 1996	Substantially Equivalent	Cordis Corp.
K961107	B. BRAUN GUIDEWIRES	Oct 01, 1996	Substantially Equivalent	B.Braun Medical, Inc.
K962266	0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING	Sep 10, 1996	Substantially Equivalent	Biocompatibles Cardiovascular, Inc.
K961777	ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404	Jul 31, 1996	Substantially Equivalent	Cardio Metrics, Inc.
K961445	RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL	Jul 09, 1996	Substantially Equivalent	Terumo Medical Corp.
K961271	USCI COMMANDER SERIES GUIDE WIRES	Jun 27, 1996	Substantially Equivalent	C.R. Bard, Inc.
K961232	0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP	Jun 26, 1996	Substantially Equivalent	Biocompatibles , Ltd.
K960755	CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS	May 23, 1996	Substantially Equivalent	Medtronic Cardiac Surgery, Medtronic, Inc.
K960718	LRM	May 21, 1996	Substantially Equivalent	Lake Region Mfg., Inc.
K955304	CRICKET	May 16, 1996	Substantially Equivalent	Microvena Corp.
K961015	SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE	May 15, 1996	Substantially Equivalent	Scimed Life Systems, Inc.
K960657	SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE	Apr 29, 1996	Substantially Equivalent	Scimed Life Systems, Inc.
K960563	SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES	Apr 29, 1996	Substantially Equivalent	Scimed Life Systems, Inc.
K954622	IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK	Apr 29, 1996	Substantially Equivalent	Boston Scientific /International Technologies
K954552	RAILWIRE	Apr 29, 1996	Substantially Equivalent	Boston Scientific /International Technologies
K955135	0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING	Apr 09, 1996	Substantially Equivalent	Biocompatibles , Ltd.
K955175	ACS ANCHOR EXCHANGE DEVICE	Apr 05, 1996	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K955637	ESSENCE GUIDEWIRE	Mar 11, 1996	Substantially Equivalent	Cordis Neurovascular, Inc.
K955551	CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404	Feb 28, 1996	Substantially Equivalent	Cardio Metrics, Inc.
K955801	RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD	Feb 02, 1996	Substantially Equivalent	Terumo Medical Corp.
K943896	GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS	Dec 22, 1995	Substantially Equivalent	Datascope Corp.
K952860	THE NINER NITINOL GUIDEWIRE	Dec 13, 1995	Substantially Equivalent	Microvena Corp.
K935998	ENTERPRISE	Nov 17, 1995	Substantially Equivalent	Camp Intl., Inc.
K954913	CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)	Nov 07, 1995	Substantially Equivalent	Cardio Metrics, Inc.
K953760	CORDIS WIZDOM STEERABLE GUIDEWIRE	Nov 07, 1995	Substantially Equivalent	Cordis Corp.
K953533	RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL	Oct 18, 1995	Substantially Equivalent	Terumo Medical Corp.
K953023	PRECEDER GUIDEWIRE	Sep 21, 1995	Substantially Equivalent	Boston Scientific Corp
K952562	CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE	Aug 29, 1995	Substantially Equivalent	Cardio Metrics, Inc.
K952430	FINESSE GUIDEWIRE CORONARY	Aug 18, 1995	Substantially Equivalent	Flexmedics
K952067	CORDIS STEERABLE GUIDEWIRE	Jul 20, 1995	Substantially Equivalent	Cordis Corp.
K945934	URESIL(R) GUIDEWIRE	Jul 10, 1995	Substantially Equivalent	Uresil Corp.
K943390	FLEXFINDER GUIDEWIRE	Jun 27, 1995	Substantially Equivalent	Flexmedics
K951307	BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES	Jun 22, 1995	Substantially Equivalent	Baxter Healthcare Corp
K950216	SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE	Jun 22, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K951109	C-THRU CORONARY GUIDE WIRE	Jun 08, 1995	Substantially Equivalent	Schneider (Europe) GmbH
K945379	PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING	Jun 05, 1995	Substantially Equivalent	Boston Scientific Corp
K943358	NAVIGUIDE HYDROPHILIC GUIDE WIRE	Jun 02, 1995	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K950835	SCIMED CHOICE PT PTCA GUIDE WIRE	May 25, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K950752	ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS	May 15, 1995	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K950535	SCIMED SCEPTOR EXCHANGE GUIDE WIRE	Apr 28, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K950534	SCIMED SCEPTOR PTCA GUIDE WIRE	Apr 28, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K950352	PRECEDER GUIDEWIRE	Apr 28, 1995	Substantially Equivalent	Boston Scientific Corp
K950316	CORDIS STEERABLE GUIDEWIRES	Apr 14, 1995	Substantially Equivalent	Cordis Corp.
K950266	SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE	Apr 14, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K950069	DASHER-14	Apr 12, 1995	Substantially Equivalent	Target Therapeutics
K950156	ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE	Apr 05, 1995	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K950141	SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE	Mar 31, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K950113	SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE	Mar 31, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K946356	M-PATH NITINOL GUIDEWIRE	Mar 31, 1995	Substantially Equivalent	Microvena Corp.
K946240	SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE	Mar 31, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K946180	SCIMED(R) ENTRE PTCA GUIDE WIRE	Mar 17, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K945129	SCIMED CHIOCE PLUS PTCA GUIDE WIRE	Mar 03, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K946029	ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT	Feb 24, 1995	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K944677	SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES	Feb 08, 1995	Substantially Equivalent	Scimed Peripheral Interventions
K945159	SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE	Dec 30, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K943522	THE PROMPT GUIDWIRE	Dec 19, 1994	Substantially Equivalent	Cordis Corp.
K942453	GUIDE WIRE	Dec 08, 1994	Substantially Equivalent	Boston Scientific Corp
K943022	CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE	Sep 19, 1994	Substantially Equivalent	Cardio Metrics, Inc.
K943340	CORDIS STEERABLE GUIDEWIRE	Sep 16, 1994	Substantially Equivalent	Cordis Corp.
K941710	SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES	Sep 01, 1994	Substantially Equivalent	Scimed Peripheral Interventions
K942333	SCIMED EN TRE' III PTCA GUIDE WIRE	Aug 31, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K942382	MS AMPLATZ EXTRA STIFF GUIDE WIRE	Aug 22, 1994	Substantially Equivalent	Meadox Surgimed, Inc.
K940984	CARDIOMETRICS DUALFLOW SWITCH BOX	Aug 18, 1994	Substantially Equivalent	Cardio Metrics, Inc.
K935232	HYDROTORQUE GUIDE WIRE	Jul 20, 1994	Substantially Equivalent	Kingston Technologies, Inc.
K942066	ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE	Jul 18, 1994	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K935997	PLATINUM PLUS GUIDEWIRE	Jun 17, 1994	Substantially Equivalent	Boston Scientific Corp
K941485	CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES	May 31, 1994	Substantially Equivalent	Cardio Metrics, Inc.
K941895	SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING	May 24, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K941229	ONTRAC STEERABLE GUIDEWIRE	May 12, 1994	Substantially Equivalent	Lake Region Mfg., Inc.
K935170	CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS	Mar 31, 1994	Substantially Equivalent	Lake Region Mfg., Inc.
K936032	TORQUE DEVICE	Mar 15, 1994	Substantially Equivalent	Merit Medical Systems, Inc.
K935905	SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP	Mar 10, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K930982	ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE	Feb 24, 1994	Substantially Equivalent	Cordis Corp.
K935577	SCIMED ENTRE II PTCA GUIDE WIRE	Feb 14, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K933334	MAGIC TORQUE GUIDEWIRE	Jan 26, 1994	Substantially Equivalent	Boston Scientific Corp
K935022	SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION	Jan 18, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K934602	ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE	Dec 16, 1993	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K934339	LOC GUIDE WIRE EXTENSION	Dec 09, 1993	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K934474	PILOT CARDIOVASCULAR SYSTEMS 2 CM PILOT WIRE	Nov 08, 1993	Substantially Equivalent	Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard
K933517	AUTOMATIC PULL BACK DEVICE	Oct 15, 1993	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K934359	SCIMED STRIKE STEERABLE GUIDE WIRE	Oct 07, 1993	Substantially Equivalent	Scimed Peripheral Interventions
K934122	SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES	Oct 07, 1993	Substantially Equivalent	Scimed Peripheral Interventions
K933466	USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING	Oct 01, 1993	Substantially Equivalent	C.R. Bard, Inc.
K932801	CARDIMA SEEKER AND STUBBIE GUIDEWIRES	Sep 01, 1993	Substantially Equivalent	Cardima, Inc.
K925947	B-D ARTERIAL BLOOD CONTAINMENT DEVICE	Aug 20, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K924558	ARROW BLOOD CONTAINMENT DEVICE	Aug 19, 1993	Substantially Equivalent	Arrow Intl., Inc.
K924385	NEW HYDROPHILIC COATING FOR WIRE GUIDES	Aug 15, 1993	Substantially Equivalent	Arrow Intl., Inc.
K931327	PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE	Jul 14, 1993	Substantially Equivalent	Peripheral Systems Group
K930787	LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT	Jul 09, 1993	Unknown	Advanced Surgical, Inc.
K931584	SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.	Jul 01, 1993	Substantially Equivalent	Scimed
K931514	SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY	Jun 25, 1993	Substantially Equivalent	Scimed Life Systems, Inc.
K931577	SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI	Jun 23, 1993	Substantially Equivalent	Schneider Intl., Ltd.
K925852	TERUMO CORONARY GUIDE WIRE	Jun 10, 1993	Substantially Equivalent	Terumo Medical Corp.
K931171	DOC-TITE(TM) GUIDE WIRE EXTENSION	Jun 04, 1993	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K925979	DUAL LUMEN L-CATH CATHETER SYSTEM	May 27, 1993	Substantially Equivalent	Luther Medical Products, Inc.
K930961	CATHETER GUIDEWIRE (PERIPHERAL USE)	May 26, 1993	Substantially Equivalent	Target Therapeutics
K925342	MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE	May 06, 1993	Substantially Equivalent	Medtronics Interventional Vascular
K930622	AMPLATZ GUIDEWIRES	Apr 29, 1993	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K926457	SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR	Apr 08, 1993	Substantially Equivalent	Scimed Life Systems, Inc.
K930091	CORDIS REFLEX STEERABLE GUIDEWIRE	Apr 07, 1993	Substantially Equivalent	Cordis Corp.
K925074	USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING	Mar 01, 1993	Substantially Equivalent	C.R. Bard, Inc.
K922060	.25' ULTRA-SELECT GUIDEWIRE	Feb 23, 1993	Substantially Equivalent	Microvena Corp.
K925833	CORDIS STEERABLE GUIDEWIRE	Feb 12, 1993	Substantially Equivalent	Cordis Corp.
K925804	SCHNEIDER HYDRO-SIL GUIDEWIRE	Feb 12, 1993	Substantially Equivalent	Schneider Intl., Ltd.
K925381	ACS HI-TORQUE BALANCE(TM) GUIDE WIRE	Feb 12, 1993	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K915554	HI-TORQUE SPORT-T(TM) GUIDE WIRE	Feb 09, 1993	Substantially Equivalent	Peripheral Systems Group
K923696	CORDIS VIERA GUIDEWIRE	Feb 03, 1993	Substantially Equivalent	Cordis Corp.
K922787	ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION	Jan 06, 1993	Substantially Equivalent	Echocath, Inc.
K922674	NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE	Dec 21, 1992	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K920891	ROADRUNNER(TM) WIRE GUIDE, MODIFICATION	Dec 21, 1992	Substantially Equivalent	Cook, Inc.
K922706	SCIMED SIDELINER	Dec 10, 1992	Substantially Equivalent	Scimed
K922536	TORQUE DEVICE	Dec 10, 1992	Substantially Equivalent	Procedure Products, Inc.
K924987	TAPER GUIDEWIRES	Dec 08, 1992	Substantially Equivalent	Target Therapeutics
K924202	RADIFOCUS(R) (CATHETER) GUIDE WIRE	Nov 23, 1992	Substantially Equivalent	Terumo Medical Corp.
K922912	SEEKER LITE - 10	Nov 17, 1992	Substantially Equivalent	Target Therapeutics
K924009	INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE	Nov 06, 1992	Substantially Equivalent	Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard
K923134	CORDIS STEERABLE GUIDEWIRE	Oct 26, 1992	Substantially Equivalent	Cordis Corp.
K920824	ROADRUNNER RLTF GUIDE WIRE	Oct 16, 1992	Substantially Equivalent	Cook, Inc.
K923240	BAXTER SENSOR CORONARY GUIDEWIRE	Sep 23, 1992	Substantially Equivalent	Baxter Healthcare Corp
K921702	MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI	Sep 21, 1992	Substantially Equivalent	Merit Medical Systems, Inc.
K920884	GUIDEWIRES, VARIOUS TYPES	Aug 19, 1992	Substantially Equivalent	Acme-Monaco Corp.
K922302	JAGWIRE(TM) RECANALIZATION GUIDEWIRE	Jul 24, 1992	Substantially Equivalent	Boston Scientific Corp
K922410	SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL	Jul 23, 1992	Substantially Equivalent	Scimed Life Systems, Inc.
K915723	.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE	Jun 09, 1992	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K914194	SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE	Jun 09, 1992	Substantially Equivalent	Scimed Life Systems, Inc.
K914986	GUIDE WIRES, MODIFICATION	May 20, 1992	Substantially Equivalent	E-Z-Em, Inc.
K915496	DESERET GUIDEWIRE INTRODUCER	Feb 27, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K914531	STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES	Feb 27, 1992	Substantially Equivalent	Arrow Intl., Inc.
K915115	GUIDER DASHER	Feb 14, 1992	Substantially Equivalent	Target Therapeutics
K915114	GUIDE WIRE EXTENSION	Feb 11, 1992	Substantially Equivalent	Target Therapeutics
K914032	NITINOL SEEKER(R) GUIDE WIRES	Feb 11, 1992	Substantially Equivalent	Target Therapeutics
K914031	GUIDER-22	Feb 11, 1992	Substantially Equivalent	Target Therapeutics
K914030	GUIDER, DASHER	Feb 11, 1992	Substantially Equivalent	Target Therapeutics
K914828	010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF	Jan 08, 1992	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K914581	HEART TECHNOLOGY WIRECLIP	Jan 06, 1992	Substantially Equivalent	Heart Technology, Inc.
K914863	CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT	Dec 18, 1991	Substantially Equivalent	Cordis Corp.
K914138	ONTRAC	Dec 13, 1991	Substantially Equivalent	Lake Region Mfg., Inc.
K912293	REMOVE LABELING RESTRICT FROM GUIDE WIRES	Dec 05, 1991	Substantially Equivalent	Target Therapeutics
K913074	0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE	Nov 05, 1991	Substantially Equivalent	Terumo Medical Corp.
K913631	.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE	Oct 28, 1991	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K913353	VASCULAR GUIDE WIRE	Oct 23, 1991	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K913328	.010 HI-TORQUE PLUS(TM) GUIDE WIRE	Oct 23, 1991	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K913178	ACS VSW GUIDE WIRE	Oct 08, 1991	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K912798	AMPLANTZ AND BENTSON GUIDEWIRES	Sep 23, 1991	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K912878	OPEN ENDED GUIDEWIRE	Sep 11, 1991	Substantially Equivalent	Lake Region Mfg., Inc.
K912156	SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE	Sep 06, 1991	Substantially Equivalent	Schneider Intl., Ltd.
K911547	MAGNUM-MEIER RECANALIZATION GUIDEWIRE	Jul 05, 1991	Substantially Equivalent	Schneider Intl., Ltd.
K911460	.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP	Jun 25, 1991	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K910969	TORQUE DEVICE FOR A GUIDE WIRE	May 16, 1991	Substantially Equivalent	Terumo Corp.
K910280	ULTRA-SELECT PTCA GUIDEWIRE	Apr 19, 1991	Substantially Equivalent	Microvena Corp.
K905423	CORDIS REFLEX STEERABLE GUIDEWIRE	Mar 01, 1991	Substantially Equivalent	Cordis Corp.
K905548	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE	Feb 25, 1991	Substantially Equivalent	Mallinckrodt Medical
K904582	QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE	Feb 25, 1991	Substantially Equivalent	Meadox Surgimed, Inc.
K905639	TORQUE HANDLE DEVICE FOR GUIDEWIRE	Feb 20, 1991	Substantially Equivalent	Lake Region Mfg., Inc.
K905581	SILICONE COATED GUIDEWIRES	Feb 19, 1991	Substantially Equivalent	Lake Region Mfg., Inc.
K905502	.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP	Feb 04, 1991	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K905432	DATASCOPE INTERLOCK GUIDE WIRE EXTENSION	Jan 30, 1991	Substantially Equivalent	Datascope Corp.
K904477	GUIDEWIRE	Dec 06, 1990	Substantially Equivalent	Datascope Corp.
K902612	CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT	Dec 03, 1990	Substantially Equivalent	Cordis Corp.
K903923	USCI(R) SILK (TM) GUIDE WIRE	Nov 21, 1990	Substantially Equivalent	C.R. Bard, Inc.
K901899	ROADRUNNER WIRE GUIDE	Sep 27, 1990	Substantially Equivalent	Cook, Inc.
K902755	.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP	Sep 04, 1990	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K902207	ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE	Aug 08, 1990	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K902153	TEFLON COATED GUIDEWIRE	Jul 31, 1990	Substantially Equivalent	Guidewire Technologies, Inc.
K902152	MOVABLE CORE GUIDEWIRE	Jul 31, 1990	Substantially Equivalent	Guidewire Technologies, Inc.
K901347	DATASCOPE SLIDEWIRE(TM)	Jun 21, 1990	Substantially Equivalent	Datascope Corp.
K900386	ACS ADVANCED CONCEPT GUIDE WIRE	Jun 12, 1990	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K901224	INSITE STEERABLE GUIDEWIRE	Jun 11, 1990	Substantially Equivalent	Lake Region Mfg., Inc.
K895899	FLEXMEDICS GUIDEWIRE .012 ONLY	May 23, 1990	Substantially Equivalent	Flexmedics
K897152	CRAGG CONVERTIBLE WIRE	Feb 22, 1990	Substantially Equivalent	Boston Scientific Corp
K896379	ACS GOLD SERIES ELASTINITE GUIDE WIRE	Feb 02, 1990	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K895903	IVT 0.014 GUIDE WIRE	Jan 04, 1990	Substantially Equivalent	Intensive Technology, Inc.
K894940	DATASCOPE STEERING HANDLE	Nov 01, 1989	Substantially Equivalent	Datascope Corp.
K894633	CORDIS STEERABLE COATED GUIDEWIRE	Oct 17, 1989	Substantially Equivalent	Cordis Corp.
K894318	DATASCOPE INTERLOCK GUIDE WIRE EXTENSION	Oct 12, 1989	Substantially Equivalent	Datascope Corp.
K893626	FLEXMEDICS GUIDEWIRE	Sep 26, 1989	Substantially Equivalent	Flexmedics
K890959	GUIDEWIRE	Sep 12, 1989	Substantially Equivalent	Guidewire Technologies, Inc.
K890404	USCI PROBE LINX EXTENSION WIRE	Aug 17, 1989	Substantially Equivalent	C.R. Bard, Inc.
K884183	BURRON TEFLON-COATED GUIDEWIRE	Aug 03, 1989	Substantially Equivalent	Burron Medical, Inc.
K890807	GUIDE WIRE INTRODUCER	Jun 20, 1989	Substantially Equivalent	Datascope Corp.
K890505	USCI GREY/BLACK GUIDE WIRE	Jun 20, 1989	Substantially Equivalent	C.R. Bard, Inc.
K890207	INTERVENTIONAL PRODUCTS - GUIDE WIRES	May 31, 1989	Substantially Equivalent	E-Z-Em, Inc.
K883880	KATZEN THROMBOLYSIS GUIDEWIRE	Apr 06, 1989	Substantially Equivalent	Medi-Tech, Inc.
K882507	ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.	Mar 31, 1989	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K884895	ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE	Feb 06, 1989	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K884490	INTRODUCER SAFETY SYRINGE	Jan 17, 1989	Substantially Equivalent	Arrow Intl., Inc.
K884647	USCI ADJUSTABLE TIP GUIDE WIRE	Jan 12, 1989	Substantially Equivalent	C.R. Bard, Inc.
K884274	BUCHBINDER MULTIFLEX GUIDEWIRE	Dec 27, 1988	Substantially Equivalent	Medtronic Vascular
K884262	ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE	Dec 21, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K884198	TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE	Dec 13, 1988	Substantially Equivalent	Target Therapeutics
K883579	CORONARY GUIDE WIRE	Nov 04, 1988	Substantially Equivalent	Datascope Corp.
K882804	0.014 PERIPHERAL GUIDE WIRE	Oct 28, 1988	Substantially Equivalent	Intensive Technology, Inc.
K882928	TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE	Sep 27, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K880288	TRU-TRAC TORQUE GUIDEWIRE	Sep 12, 1988	Substantially Equivalent	N-S Medical Products
K880287	TRU-TRAC COILED GUIDEWIRE	Sep 12, 1988	Substantially Equivalent	N-S Medical Products
K882321	ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT	Aug 30, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K880762	TAPER FLEX-TIP STEERABLE GUIDEWIRE	Aug 19, 1988	Substantially Equivalent	Target Therapeutics
K880761	TAPER-22 STEERABLE GUIDEWIRE	Aug 19, 1988	Substantially Equivalent	Target Therapeutics
K880722	COATING FOR WIRE GUIDE	Aug 19, 1988	Substantially Equivalent	Cook, Inc.
K881897	ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW	Aug 03, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K880332	MEDRAD OPEN ENDED GUIDEWIRE	Jul 28, 1988	Substantially Equivalent	Medrad, Inc.
K881787	ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE	Jul 25, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K880927	VASCU-CARE ANGIOSCOPE	May 16, 1988	Substantially Equivalent	Vascu-Care, Inc.
K874202	ACS HI-TORQUE GUIDE WIRES	Apr 28, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K873972	GUIDE WIRE INTRODUCER	Apr 01, 1988	Substantially Equivalent	Target Therapeutics
K875323	MODIFIED SCHNEIDER-SHILEY WIRE TORQUER	Mar 28, 1988	Substantially Equivalent	Schneider-Shilley (Usa)
K873403	CORDIS STEERABLE GUIDEWIRE	Mar 22, 1988	Substantially Equivalent	Cordis Corp.
K874542	TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES	Mar 07, 1988	Substantially Equivalent	Toray Industries (America), Inc.
K874776	ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR	Feb 17, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K871850	TELEFLEX STEERABLE GUIDEWIRE	Jan 27, 1988	Substantially Equivalent	Teleflexmedical, Inc.
K873942	GUIDE WIRE BOWL	Dec 23, 1987	Substantially Equivalent	Condor Medical
K865017	ANGIOSCOPE	Dec 15, 1987	Substantially Equivalent	Mansfield Scientific, Inc.
K873543	STUBBIE STEERABLE GUIDEWIRE	Dec 03, 1987	Substantially Equivalent	Target Therapeutics
K871517	OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE	Nov 30, 1987	Substantially Equivalent	Olympus Corp.
K871882	LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)	Sep 15, 1987	Substantially Equivalent	Lake Region Mfg., Inc.
K871492	AIS ANGIOSCOPE	Sep 14, 1987	Substantially Equivalent	Advanced Interventional Systems, Inc.
K872220	ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)	Aug 21, 1987	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K871137	MINISTIK MINI PUNCTURE SET CATALOG CODE #57505	Jul 16, 1987	Substantially Equivalent	Dlp, Inc.
K870664	GUIDE WIRE	Mar 25, 1987	Substantially Equivalent	Datascope Corp.
K864316	TARGET THERAPEUTICS TAPER GUIDE WIRE	Mar 20, 1987	Substantially Equivalent	Target Therapeutics
K864787	SCHNEIDER-SHILEY GUIDE WIRE	Feb 19, 1987	Substantially Equivalent	Shiley, Inc.
K864058	AMPLATZ MOVEABLE CORE GUIDEWIRE	Feb 19, 1987	Substantially Equivalent	Lake Region Mfg., Inc.
K864585	ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH	Dec 05, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K863138	TERUMO RADIFOCUS GUIDE WIRE	Nov 20, 1986	Substantially Equivalent	Terumo Medical Corp.
K862937	BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE	Sep 24, 1986	Substantially Equivalent	Versaflex Delivery Systems, Inc.
K863178	UMI STEERABLE TORQUE GUIDE WIRE	Sep 19, 1986	Substantially Equivalent	Universal Medical Instrument Corp.
K862983	ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES	Sep 19, 1986	Substantially Equivalent	Target Therapeutics
K862360	ACS HI-TORQUE FLEX-T GUIDE WIRE	Sep 11, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K862567	ACS WIRE SHAPER	Sep 04, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K860430	THE NAVIGATOR STEERABLE GUIDE WIRE	Jul 18, 1986	Substantially Equivalent	Meadox Surgimed, Inc.
K862409	SNAP-ON TORQUER	Jul 11, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K861115	TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE	Jul 11, 1986	Substantially Equivalent	Toray Industries (America), Inc.
K862048	SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM	Jun 19, 1986	Substantially Equivalent	Murex Corp.
K861606	SCHNEIDER-SHILEY WIRE TORQUER	Jun 09, 1986	Substantially Equivalent	Shiley, Inc.
K861765	ACS WHOLEY HI-TORQUE GUIDE WIRE	May 30, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K861574	ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE	May 28, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K860258	TELEFLEX TEFLON COATED GUIDEWIRE	May 20, 1986	Substantially Equivalent	Teleflexmedical, Inc.
K860841	GUIDE WIRE INTRODUCER	Apr 28, 1986	Substantially Equivalent	Target Therapeutics
K860840	GUIDED WIRE TORQUER	Apr 23, 1986	Substantially Equivalent	Target Therapeutics
K854912	ANGIOMED GUIED WIRES	Apr 16, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K860533	(.O38) HI-TORQUE GUIDE WIRES	Mar 31, 1986	Substantially Equivalent	Target Therapeutics
K854830	ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES	Mar 31, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K855089	PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505	Feb 18, 1986	Substantially Equivalent	Dlp, Inc.
K854511	ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET	Feb 10, 1986	Substantially Equivalent	Electro-Catheter Corp.
K853999	GUIDE WIRE	Nov 05, 1985	Substantially Equivalent	Target Therapeutics
K850677	TELEFLEX GUIDEWIRE	Sep 17, 1985	Substantially Equivalent	Teleflexmedical, Inc.
K852354	WHOLEY HI-TORQUE GUIDE WIRES	Jul 29, 1985	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K850828	WIRE, GUIDE - MODIFICATION	Jun 26, 1985	Substantially Equivalent	Lake Region Mfg., Inc.
K850827	GUIDE, WIRE, ANGIOGRAPHIC	Jun 26, 1985	Substantially Equivalent	Lake Region Mfg., Inc.
K852123	WHOLEY HI-TORQUE GUIDE WIRES	Jun 19, 1985	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K851574	MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T	Jun 19, 1985	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K840756	BIOPATCH BOVINE PERICARDIAL PATCH	Feb 08, 1985	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K841926	HYDROGLIDE SPRING GUIDE WIRES	Jan 02, 1985	Substantially Equivalent	Argon Medical Corp.
K843012	WIREGUIDE OR GUIDEWIRE	Nov 29, 1984	Substantially Equivalent	Medi-Tech, Inc.
K840391	ANGIOGRAPHIC PROCEDURE TRAY	Aug 27, 1984	Substantially Equivalent	Triad Medical Division
K841071	PRESSURE MANOMETER	Apr 17, 1984	Substantially Equivalent	Interventional Medical, Inc.
K834223	CARDIOVASCULAR SPRING GUIDE WIRE	Feb 13, 1984	Substantially Equivalent	Mallinckrodt Critical Care
K834237	GRADUATED GUIDE WIRE BOWL 8	Feb 04, 1984	Substantially Equivalent	Sterile Design, Inc.
K833574	PERCUTANEOUS SHEATH INTRODUCER TRAYS	Jan 11, 1984	Substantially Equivalent	Intermed, Inc.
K832607	OPEN END SPRING GUIDE	Dec 27, 1983	Substantially Equivalent	C.R. Bard, Inc.
K831839	STAINLESS STEEL GUIDE WIRE	Jul 18, 1983	Substantially Equivalent	Quinton, Inc.
K822586	TEFLON COATED GUIDE WIRES & CATHETER	Oct 18, 1982	Substantially Equivalent	Universal Medical Instrument Corp.
K822597	GUIDE WIRE	Sep 21, 1982	Substantially Equivalent	Vertex Medical Corp.
K821190	GUIDE WIRE	Aug 31, 1982	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K820699	CATHETER GUIDE WIRE	Apr 09, 1982	Substantially Equivalent	Quest Medical, Inc.
K810675	ARROW RADIAL ARTERY CATHETERIZATION SET	Mar 27, 1981	Substantially Equivalent	Arrow Intl., Inc.
K802473	BENZALKONIUM-HEPARIN COATED GUIDEWIRES	Nov 12, 1980	Substantially Equivalent	Medrad, Inc.
K802260	VASCULAR CATHETER WIREGUIDES	Oct 10, 1980	Substantially Equivalent	Stanco Medical, Inc.
K791276	PERVENOUS LEAD INTRODUCER SYSTEM	Jul 24, 1979	Substantially Equivalent	Cordis Corp.
K790882	LEAD INTRODUCER SET	Jun 11, 1979	Substantially Equivalent	Introstat
K790258	MOVABLE CORE SAFETY GUIDE	Feb 23, 1979	Substantially Equivalent	Cordis Corp.
K781561	ANGIOGRAPHIC GUIDE WIRE	Nov 07, 1978	Substantially Equivalent	Wilson Medical Instruments Co.
K781393	VARIABLE STIFFNESS WIRE GUIDE	Oct 30, 1978	Substantially Equivalent	Cook, Inc.
K780438	SAFETY SPRING GUIDES, TEFLON COATED	Jun 28, 1978	Substantially Equivalent	C.R. Bard, Inc.
K780493	ELECATH PLASTIC JACKETED GUIDEWIRE	Apr 10, 1978	Substantially Equivalent	Electro-Catheter Corp.
K772021	TRC STAINLESS STEEL SAFETY SPRING GUIDES	Nov 02, 1977	Substantially Equivalent	Usci, Div. C.R. Bard, Inc.
K771231	ARTEOIAL LINE KIT	Aug 16, 1977	Substantially Equivalent	Medical Disposables Intl., Inc.
K771230	PERCUTANEOUS INTRODUCER SHEATH SET	Aug 16, 1977	Substantially Equivalent	Medical Disposables Intl., Inc.
K770977	CARDIOVASCULAR SPRING GUIDES	Jun 14, 1977	Substantially Equivalent	Lake Region Mfg., Inc.
K760944	ANGIOGRAPHIC GUIDEWIRE	Dec 10, 1976	Substantially Equivalent	Medrad, Inc.