Product Code: DYB FDA class 2 21 CFR 870.1340

Introducer, Catheter

Cardiovascular

The Catheter Introducer is a cardiovascular device used to facilitate the insertion and placement of catheters and other instruments into blood vessels, providing a stable access sheath during vascular procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYB and the applicable regulation is 21 CFR 870.1340, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

683

FEI Numbers

268

Registration Numbers

268

Unique Applicants

285

Years Active

Basic Information

Product Code: DYB
Device Class: FDA class 2
Regulation Number: 870.1340
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 683 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251051	AuST Steerable Sheath	Apr 30, 2025	Substantially Equivalent	CenterPoint Systems LLC
K250909	Prelude Wave Hydrophilic Sheath Introducer	Apr 25, 2025	Substantially Equivalent	Merit Medical Systems, Inc.
K243954	PeriCross Epicardial Access Kit	Apr 24, 2025	Substantially Equivalent	CIRCA Scientific, Inc.
K244046	Edwards eSheath Optima introducer set	Mar 27, 2025	Substantially Equivalent	Edwards Lifesciences
K250468	iSLEEVE Introducer Set	Mar 20, 2025	Substantially Equivalent	Boston Scientific
K243928	ViaOne Epicardial Access System	Mar 20, 2025	Substantially Equivalent	CardioVia Ltd.
K250439	Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca	Mar 16, 2025	Substantially Equivalent	Contract Medical International GmbH
K243493	Agilis NxT Steerable Introducer Dual-Reach	Dec 13, 2024	Substantially Equivalent	Abbott Medical
K242520	Element Vascular Access System	Nov 20, 2024	Substantially Equivalent	Penumbra, Inc.
K242756	Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)	Nov 08, 2024	Substantially Equivalent	Pulnovo Medical (Wuxi) Co., Ltd
K243061	SonoStik Guide Wire Introducer	Nov 04, 2024	Substantially Equivalent	SonoStik, LLC
K242106	AuST Steerable Sheath	Oct 04, 2024	Substantially Equivalent	CenterPoint Systems LLC
K241230	Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008	Sep 17, 2024	Substantially Equivalent	Togo Medikit Co., Ltd.
K240600	SafeCross Vascular Introducer System (4001)	Sep 06, 2024	Substantially Equivalent	East End Medical I, LLC
K242169	Morph DNA Steerable Introducer Sheath	Aug 23, 2024	Substantially Equivalent	BioCardia
K242248	Introducer Sheath Kits	Aug 22, 2024	Substantially Equivalent	Beijing Demax Medical Technology Co., Ltd.
K240957	Catapult Guide Sheath	Aug 14, 2024	Substantially Equivalent	Contract Medical International GmbH
K241708	Abiomed 14Fr Low Profile Introducer Kit	Aug 06, 2024	Substantially Equivalent	Abiomed Inc.
K241145	TLAB® Transvenous Liver Biopsy System (TF-18C)	Aug 01, 2024	Substantially Equivalent	Argon Medical Devices, Inc.
K241370	Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)	Jun 13, 2024	Substantially Equivalent	Abbott Medical
K240829	AuST Steerable Sheath	May 01, 2024	Substantially Equivalent	CenterPoint Systems LLC
K240589	Micropuncture Introducer Sets; Micropuncture Pedal Access Sets	Mar 25, 2024	Substantially Equivalent	Cook Medical
K233708	NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)	Feb 16, 2024	Substantially Equivalent	Synaptic Medical Corporation
K233959	EPi-Ease Epicardial Access Device (EAS)	Feb 13, 2024	Substantially Equivalent	AtriCure, Inc.
K240004	CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer	Jan 31, 2024	Substantially Equivalent	CIRCA Scientific, Inc.
K231227	SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath	Dec 20, 2023	Substantially Equivalent	Baylis Medical Company Inc.
K233691	FlexCath Cross Transseptal Solution	Dec 17, 2023	Substantially Equivalent	Acutus Medical, Inc.
K233646	Intri24 Introducer Sheath (52-101)	Dec 12, 2023	Substantially Equivalent	Inari Medical, Inc.
K233432	10F Sheath and Dilator Set	Dec 08, 2023	Substantially Equivalent	Argon Medical Devices, Inc.
K233503	14F iSLEEVE Introducer Set	Nov 30, 2023	Substantially Equivalent	Boston Scientific Corporation
K232260	Thinline Sheath Introducer	Sep 27, 2023	Substantially Equivalent	Inneuroco Inc.
K231108	Talon Transseptal Sheath	Sep 27, 2023	Substantially Equivalent	Inari Medical, Inc.
K231828	Pounce Sheath	Sep 07, 2023	Substantially Equivalent	Surmodics, Inc.
K231412	CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)	Jul 10, 2023	Substantially Equivalent	Biosense Webster, Inc.
K230631	Kodiak Dual Port Coaxial Introducer Kit	May 22, 2023	Substantially Equivalent	Argon Medical Devices
K230704	RAIN Sheath Tibial Pedal Introducer	Apr 24, 2023	Substantially Equivalent	Cordis US Corp.
K230283	Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)	Mar 01, 2023	Substantially Equivalent	Abbott Medical
K222184	Introducer Sheath Kits	Feb 21, 2023	Substantially Equivalent	Beijing Demax Medical Technology Co., Ltd.
K230051	14F iSLEEVE Introducer Set	Feb 03, 2023	Substantially Equivalent	Boston Scientific Corporation
K223872	Low Profile Companion Sheath	Jan 19, 2023	Substantially Equivalent	Merit Medical Systems, Inc.
K221655	Multiflex Steerable Sheath	Nov 14, 2022	Substantially Equivalent	VizaraMed, Inc.
K222113	Abiomed 14Fr Low Profile Introducer Set	Oct 13, 2022	Substantially Equivalent	Abiomed Inc.
K222647	INT Introducer Set	Sep 13, 2022	Substantially Equivalent	Shanghai Kindly Medical Instruments Co., Ltd
K221914	Catapult Guide Sheath	Jul 29, 2022	Substantially Equivalent	Contract Medical International GmbH
K213582	Epicardial Access System	Jun 30, 2022	Substantially Equivalent	Baylis Medical Company Inc.
K221440	Liverty TIPS Access Set	May 31, 2022	Substantially Equivalent	Bard Peripheral Vascular, Inc
K220414	VersaCross Connect Transseptal Dilator	May 09, 2022	Substantially Equivalent	Baylis Medical Company Inc.
K220604	EXTesia Introducer Sheath Set	Apr 27, 2022	Substantially Equivalent	Curatia Medical Co.
K212392	Intri24 Sheath	Apr 01, 2022	Substantially Equivalent	Inari Medical, Inc.
K213492	Dib UltraNav Transseptal Catheter System	Mar 24, 2022	Substantially Equivalent	Dib UltraNav Medical, LLC
K212626	PathBuilder Transseptal Guiding Introducer	Mar 23, 2022	Substantially Equivalent	Shanghai MicroPort EP MedTech Co., Ltd.
K220047	AcQCross Qx Integrated Transseptal Dilator/Needle	Feb 08, 2022	Substantially Equivalent	Acutus Medical, Inc.
K211530	PathBuilder Steerable Introducer	Feb 08, 2022	Substantially Equivalent	Shanghai MicroPort EP MedTech Co., Ltd.
K212152	Prelude IDeal 9F Hydrophilic Sheath Introducer	Jan 07, 2022	Substantially Equivalent	Merit Medical Systems
K213638	Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)	Dec 10, 2021	Substantially Equivalent	Argon Medical Devices
K213002	SCORPION Portal Vein Access Set	Oct 14, 2021	Substantially Equivalent	Argon Medical Devices
K211405	Prelude Guide Sheath	Oct 04, 2021	Substantially Equivalent	Merit Medical Systems, Inc.
K212708	Halo One Thin-Walled Guiding Sheath	Sep 23, 2021	Substantially Equivalent	C.R.Bard, Inc
K211989	Aveir Introducer	Jul 27, 2021	Substantially Equivalent	Abbott Medical
K210185	CardioCurve Steerable Sheath	Jul 23, 2021	Substantially Equivalent	Talon Surgical
K203459	SafeCross Transseptal Puncture and Introducer (TSP/I) System	Jul 06, 2021	Substantially Equivalent	East End Medical I LLC
K210627	Breezeway II	Jun 03, 2021	Substantially Equivalent	Oscor Inc.
K210685	AcQCross Qx Integrated Transseptal Dilator/Needle	Apr 06, 2021	Substantially Equivalent	Acutus Medical Inc.
K202167	Brite Tip Radianz Guiding Sheath	Feb 26, 2021	Substantially Equivalent	Cordis Corporation
K203670	Extra Large Check-Flo Introducer	Feb 16, 2021	Substantially Equivalent	Cook Incorporated
K202141	Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set	Jan 15, 2021	Substantially Equivalent	Argon Medical Devices, Inc.
K201489	Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set	Dec 22, 2020	Substantially Equivalent	Argon Medical Devices, Inc.
K202226	Lim Precision Steerable TS, Steerable Sheath, Dilator	Dec 15, 2020	Substantially Equivalent	Keystone Heart, Ltd.
K202330	Impella XR Sheath Set	Dec 07, 2020	Substantially Equivalent	Abiomed Inc.
K203179	Fortress Introducer Sheath System	Nov 20, 2020	Substantially Equivalent	Contract Medical International GmbH
K202584	iSleeve Introducer Set	Oct 06, 2020	Substantially Equivalent	Boston Scientific Corporation
K201116	Abiomed 23 Fr Sheath	Jun 15, 2020	Substantially Equivalent	Abiomed Inc.
K200258	Edwards eSheath Introducer Set	Mar 09, 2020	Substantially Equivalent	Edwards Lifesciences
K193509	AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX	Jan 17, 2020	Substantially Equivalent	Acutus Medical, Inc.
K193125	R2P Destination Slender Guiding Sheath	Jan 06, 2020	Substantially Equivalent	Terumo Medical Corporation
K192313	Halo One Thin-Walled Guiding Sheath	Dec 19, 2019	Substantially Equivalent	C.R. Bard, Inc.
K193160	Glidesheath Slender Tibial Pedal Kit	Dec 03, 2019	Substantially Equivalent	Terumo Medical Coporation
K192769	Impella CP Introducer	Nov 18, 2019	Substantially Equivalent	Abiomed, Inc.
K192106	AcQRef Introducer Sheath	Sep 03, 2019	Substantially Equivalent	Acutus Medical, Inc.
K191871	15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set	Aug 07, 2019	Substantially Equivalent	Boston Scientific Corporation
K191546	Epicardial Access System	Aug 02, 2019	Substantially Equivalent	Baylis Medical Company Inc.
K191190	Steerable Introducer	Aug 01, 2019	Substantially Equivalent	Freudenberg Medical LLC
K183066	The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model	Jul 25, 2019	Substantially Equivalent	Access Scientific, LLC
K190628	FlexSeal Introducer Sheath with Hydrophilic Coating	May 30, 2019	Substantially Equivalent	Freudenberg Medical MIS, Inc
K183655	VersaCross Transseptal Sheath	May 20, 2019	Substantially Equivalent	Baylis Medical Company Inc.
K190974	D'Vill Introducer	May 14, 2019	Substantially Equivalent	NuMED, Inc.
K190941	BioCardia 8.5 F Avance Steerable lntroducer	May 06, 2019	Substantially Equivalent	BioCardia, Inc.
K190644	Guide Sheath	Apr 18, 2019	Substantially Equivalent	Surmodics, Inc.
K190688	VersaCross Steerable Sheath, VersaCross Transseptal Dilator	Apr 17, 2019	Substantially Equivalent	Baylis Medical Company Inc.
K190369	M-Y Sheath	Apr 17, 2019	Substantially Equivalent	RAM Medical Innovations, Inc.
K181817	transGlideXT Expandable Introducer	Mar 26, 2019	Substantially Equivalent	TransAortic Medical, Inc.
K190184	iSLEEVE Introducer Set	Mar 07, 2019	Substantially Equivalent	Boston Scientific
K190098	Endophys Pressure Sensing Sheath	Mar 07, 2019	Substantially Equivalent	Endophys Holdings LLC
K181463	DuraSheath Introducer Sheath System	Dec 13, 2018	Substantially Equivalent	Contract Medical International GmbH
K181031	TSI Transseptal Introducer	Oct 26, 2018	Substantially Equivalent	Pressure Products Medical Device Manufacturing LLC
K180620	Endophys Pressure Sensing Sheath Kit	Oct 12, 2018	Substantially Equivalent	Endophys Holdings, LLC
K181088	TSP Crosser Transseptal Access System	Sep 28, 2018	Substantially Equivalent	Transseptal Solutions Ltd.
K182243	The CVC WAND Safety Introducer with Valved Peelable Sheath	Sep 18, 2018	Substantially Equivalent	Access Scientific, LLC
K180178	Introducer Set	Sep 10, 2018	Substantially Equivalent	Shanghai Kindly Medical Instruments Co., Ltd.
K181592	RAIN Sheath Transradial	Aug 15, 2018	Substantially Equivalent	Cordis Corporation
K181237	Glidesheath Slender Tibial Pedal Kit	Aug 03, 2018	Substantially Equivalent	Terumo Medical Corporation
K181855	RadialSeal Introducer Kit	Jul 26, 2018	Substantially Equivalent	Greatbatch Medical
K180785	iSLEEVE Introducer Set	Jun 22, 2018	Substantially Equivalent	Boston Scientific Corporation
K171609	Check-Flo Performer Introducer Micropuncture Radial Artery Access Set	Jun 04, 2018	Substantially Equivalent	Cook Incorporated
K180913	VSI Micro-Introducer Kit	May 09, 2018	Substantially Equivalent	Vascular Solutions, Inc.
K173831	Glidesheath Slender	May 08, 2018	Substantially Equivalent	Terumo Medical Corporation
K172980	Micropuncture Pedal Access Set	May 03, 2018	Substantially Equivalent	Cook Incorporated
K180081	RAILWAY Sheathless Access System	Apr 18, 2018	Substantially Equivalent	Cordis Corporation
K171988	Performer Guiding Sheath	Mar 30, 2018	Substantially Equivalent	Cook Incorporated
K171820	Transjugular Liver Access Sets	Mar 09, 2018	Substantially Equivalent	Cook Incorporated
K172331	Type I, Type II, Type III, Type IV	Mar 02, 2018	Unknown	Lepu Medical Technology (Beijing) Co., Ltd.
K173750	Prelude IDeal Hydrophilic Sheath Introducer	Feb 15, 2018	Substantially Equivalent	Merit Medical Systems, Inc.
K171557	AcQRef Introducer Sheath	Feb 06, 2018	Substantially Equivalent	Acutus Medical, Inc.
K173287	Elite HV Radial	Dec 21, 2017	Unknown	Galt Medical Corp.
K173685	Peel-Away Introducer Set	Dec 20, 2017	Substantially Equivalent	Cook Incorporated
K171866	Sentrant Introducer Sheath with Hydrophilic Coating	Dec 20, 2017	Substantially Equivalent	Medtronic Vascular, Inc.
K171275	Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design	Dec 20, 2017	Unknown	Cook Incorporated
K173399	Endophys Pressure Sensing Sheath Kit- 8F	Nov 30, 2017	Substantially Equivalent	Endophys Holdings, LLC
K172995	Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath	Nov 21, 2017	Substantially Equivalent	Terumo Medical Corporation
K173068	Performer Introducer	Nov 17, 2017	Substantially Equivalent	COOK Incorporated
K171206	D'Vill Introducer	Oct 20, 2017	Substantially Equivalent	NuMED, Inc.
K172099	Shoocin Introducer Kit	Oct 05, 2017	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.
K171491	R2P Destination Slender Guiding Sheath	Oct 05, 2017	Substantially Equivalent	Terumo Medical Corporation
K170020	Peel-Away Introducer Set	Sep 28, 2017	Substantially Equivalent	Cook Incorporated
K172117	Prelude Pursuit Splittable Sheath Introducer	Sep 11, 2017	Unknown	Merit Medical Systems, Inc.
K171853	Liver Access and Biopsy Sets	Aug 24, 2017	Substantially Equivalent	Cook Incorporated
K171999	Performer Introducer	Jul 31, 2017	Substantially Equivalent	Cook Incorporated
K170997	CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath	Jul 25, 2017	Substantially Equivalent	Biosense Webster, Inc.
K170775	Mini Stick ENVI Non-Vascular Introducer Kit	Jul 19, 2017	Substantially Equivalent	AngioDynamics, Inc.
K170695	VenaCure EVLT NeverTouch Direct Introducer Sheath	May 30, 2017	Substantially Equivalent	AngioDynamics, Inc.
K171081	Guider Catheter Introducer	May 09, 2017	Substantially Equivalent	Rhythm Xience, Inc. (RXI)
K170831	EpiAccess System	May 09, 2017	Substantially Equivalent	EpiEP, INc
K170668	HeartSpan Steerable Sheath Introducer	Apr 05, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K160721	Vado Steerable Sheath	Mar 07, 2017	Substantially Equivalent	KALILA MEDICAL, INC.
K170373	Flextra Steerable Introducer	Feb 27, 2017	Substantially Equivalent	Rhythm Xience, Inc. (RXI)
K163268	FlexCath Select Steerable Shealth and Dilator	Feb 02, 2017	Substantially Equivalent	Medtronic CryoCath LP
K162427	Vado Bi-Directional Steerable Sheath	Jan 27, 2017	Substantially Equivalent	KALILA MEDICAL, INC.
K162322	the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model	Nov 17, 2016	Substantially Equivalent	ACCESS SCIENTIFIC, LLC
K162097	InTRAkit	Nov 17, 2016	Substantially Equivalent	Medtronic Vascular
K162769	Pinpoint GT Introducer Needle	Nov 04, 2016	Substantially Equivalent	C.R. BARD, INC.
K153771	TXM Guiding Sheath	Sep 13, 2016	Substantially Equivalent	Texas Medical Technologies, Inc.
K162184	Edwards eSheath Introducer Set	Sep 02, 2016	Substantially Equivalent	Edward Lifesciences
K153494	HQS Introducer (Model 2064-HQS)	Aug 25, 2016	Substantially Equivalent	ALSEAL
K152913	GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle	Jul 21, 2016	Substantially Equivalent	CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
K161659	FlexSeal Introducer Sheath with Hydrophilic Coating	Jul 15, 2016	Substantially Equivalent	LIBRA MEDICAL INC.
K153533	Tearaway Introducer Sheath, MicroSlide Tearaway Introducer	Jul 05, 2016	Substantially Equivalent	GALT MEDICAL CORP.
K161183	Halo One Thin-Walled Guiding Sheath	Jun 03, 2016	Substantially Equivalent	C.R. BARD, INC
K161102	Nanostim Introducer Kit	May 19, 2016	Substantially Equivalent	ST JUDE MEDICAL, INC.
K160254	GORE DrySeal Flex Introducer Sheath	May 12, 2016	Substantially Equivalent	W.L. GORE & ASSOCIATES, INC.
K160716	The Nanostim Introducer Kit	Apr 14, 2016	Substantially Equivalent	St Jude Medical, Inc
K152194	transGlide Expandable Introducer	Apr 07, 2016	Substantially Equivalent	TRANSAORTIC MEDICAL, INC.
K153430	Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select	Mar 07, 2016	Substantially Equivalent	COOK INCORPORATED
K160272	Endophys Pressure Sensing Sheath Kit	Mar 04, 2016	Substantially Equivalent	Endophys, Inc.
K153246	PTFE Super Sheath Introducer 2.1	Feb 12, 2016	Substantially Equivalent	MEDCOMP (MEDICAL COMPONENTS, INC.)
K153197	Fortress Introducer Sheath SYstem	Jan 11, 2016	Substantially Equivalent	CONTRACT MEDICAL INTERNATIONAL GMBH
K152498	SoloPath Re-Collapsible Access System	Jan 05, 2016	Substantially Equivalent	ONSET MEDICAL CORPORATION
K151936	Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle	Dec 04, 2015	Unknown	SYNAPTIC MEDICAL LIMITED
K152173	Glidesheath	Dec 01, 2015	Substantially Equivalent	TERUMO MEDICAL CORPORATION
K152225	Edwards eSheath Introducer Set	Nov 24, 2015	Substantially Equivalent	EDWARDS LIFESCIENCES
K152381	Prelude SNAP Splittable Hydrophilic Sheath Introducer	Oct 30, 2015	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K152177	SonoStik IV Guide Wire Introducer	Oct 01, 2015	Substantially Equivalent	SONOSTIK, LLC
K151951	Destino Reach	Sep 22, 2015	Substantially Equivalent	Oscor Inc.
K152116	5.5 F Worley Advanced LVI Lateral Vein Introducer	Aug 27, 2015	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K152044	Flexor Radial Hydrophilic Introducer Access Set	Aug 14, 2015	Substantially Equivalent	COOK INCORPORATED
K152054	Confida Adaptive Sheath	Aug 07, 2015	Substantially Equivalent	Medtronic, Inc.
K142829	Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer	Jul 28, 2015	Substantially Equivalent	Cook Incorporated
K142819	Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set	Jul 24, 2015	Substantially Equivalent	COOK INCORPORATED
K142357	DuraSheath Introducer Sheath System	Jun 25, 2015	Substantially Equivalent	CONTRACT MEDICAL INTERNATIONAL GMBH
K150257	PreludeEASE Hydrophilic Sheath Introducer	Jun 19, 2015	Unknown	Merit Medical Systems, Inc.
K150186	Chariot Guiding Sheath	Jun 05, 2015	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K142445	PINPOINT GT SAFETY INTRODUCER NEEDLE	Apr 13, 2015	Substantially Equivalent	C.R. BARD, INC.
K143255	Prelude SNAP Splittable Sheath Introducer	Apr 09, 2015	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K141275	ENDOPHYS PRESSURE SENSING SHEATH KIT	Jan 07, 2015	Substantially Equivalent	ENDOPHYS, INC.
K141969	FIRSTSTIC N INTRODUCER	Dec 19, 2014	Substantially Equivalent	ARGON MEDICAL DEVICES, INC
K140793	NANOSTIM INTRODUCER KIT	Dec 17, 2014	Substantially Equivalent	ST. JUDE MEDICAL, INC.
K140768	TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT	Nov 25, 2014	Substantially Equivalent	LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD.
K142183	GLIDESHEATH SLENDER	Nov 21, 2014	Substantially Equivalent	Terumo Medical Corporation
K142684	FlexCath Select Steerable Sheath (10 French)	Nov 06, 2014	Substantially Equivalent	Medtronic CryoCath LP
K142245	EpiAccess System	Oct 29, 2014	Substantially Equivalent	EpieP, Inc.
K140543	PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER	Oct 16, 2014	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K132592	FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET	Oct 09, 2014	Substantially Equivalent	COOK, INC.
K141696	EDWARDS ESHEATH INTRODUCER SET	Sep 18, 2014	Substantially Equivalent	EDWARDS LIFESCIENCES
K140338	CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)	Aug 27, 2014	Substantially Equivalent	CREGANNA-TACTX MEDICAL
K140028	GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER	Aug 21, 2014	Substantially Equivalent	GALT MEDICAL CORP.
K140917	INTRODUCER, MODEL ADELANTE MAGNUM	Jul 09, 2014	Substantially Equivalent	Oscor Inc.
K140513	MERIT SAFETY INTRODUCER NEEDLE	Jul 09, 2014	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K140641	VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA	Jul 03, 2014	Substantially Equivalent	Boston Scientific Corporation
K133114	MICROPUNCTURE INTRODUCER SET	Jul 03, 2014	Substantially Equivalent	COOK INCORPORATED
K140871	AXERA 2 ACCESS SYSTEM	Jun 06, 2014	Substantially Equivalent	ARSTASIS, INC.
K140287	AXERA RX ACCESS SYSTEM	May 16, 2014	Substantially Equivalent	ARSTASIS, INC.
K132617	MEDTRONIC INPUT PS INTRODUCER	Apr 30, 2014	Substantially Equivalent	MEDTRONIC, INC.
K140406	DESTINO TWIST, STEERABLE GUIDING SHEATH	Apr 17, 2014	Substantially Equivalent	Oscor Inc.
K132789	FLIP INTRODUCER ACCESS KIT	Apr 17, 2014	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K140420	VADO STEERABLE SHEATH	Apr 01, 2014	Substantially Equivalent	KALILA MEDICAL, INC.
K140201	AXERA 2 ACCESS SYSTEM	Mar 28, 2014	Substantially Equivalent	ARSTASIS, INC.
K140398	EMBOL-X INTRODUCER SHEATH	Mar 19, 2014	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K140327	ULTIMUM EV HEMOSTASIS INTRODUCER	Mar 11, 2014	Substantially Equivalent	ST. JUDE MEDICAL
K131627	CATHETER INTRODUCER SHEATH	Mar 06, 2014	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K133296	XCATH	Feb 14, 2014	Substantially Equivalent	ALSEAL
K130633	INTRODUCER SETS, MODEL ADELANTE RADIAL	Feb 13, 2014	Substantially Equivalent	Oscor Inc.
K132720	HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH	Feb 12, 2014	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K140015	CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER	Feb 05, 2014	Substantially Equivalent	CARDIOSOLUTIONS INC
K123475	SHOOCIN INTRODUCER KIT	Feb 03, 2014	Substantially Equivalent	LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
K132498	VALVED TEARAWAY INTRODUCER GENERATION II	Nov 25, 2013	Substantially Equivalent	MEDCOMP (MEDICAL COMPONENTS, INC.)
K130730	V-STICK VASCULAR ACCESS SET	Nov 22, 2013	Substantially Equivalent	ARGON MEDICAL
K132030	MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING	Sep 27, 2013	Substantially Equivalent	MEDTRONIC INC.
K132164	HEARTSPAN STEERABLE INTRODUCER KIT	Sep 17, 2013	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K131148	THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH	Sep 04, 2013	Substantially Equivalent	ACCESS SCIENTIFIC, LLC
K132263	AXERA 2 ACCESS SYSTEM	Aug 19, 2013	Substantially Equivalent	ARSTASIS, INC.
K131144	AMECO SHEATH INTRODUCER	Aug 15, 2013	Substantially Equivalent	AMECO MEDICAL INDUSTRIES
K130687	2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER	Aug 15, 2013	Substantially Equivalent	MEDICAL COMPONENTS INC
K131079	CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC	Aug 01, 2013	Substantially Equivalent	CREGANNA MEDICAL DEVICES
K130855	PTFE SUPER SHEATH INTRODUCER	Jul 29, 2013	Substantially Equivalent	MARTECH MEDICAL PRODUCTS
K123714	EDWARDS EMBOL-X INTRODUCER SHEATH	Jul 24, 2013	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K131332	CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER	Jul 19, 2013	Substantially Equivalent	CARDIOSOLUTIONS INC
K131300	THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER	Jun 07, 2013	Substantially Equivalent	ACCESS SCIENTIFIC, LLC
K124046	VALVED TEARAWAY INTRODUCER GENERATION II	Jun 03, 2013	Substantially Equivalent	MEDICAL COMPONENTS INC
K130559	MOBICATH BI-DIRECTIONAL GUIDING SHEATH	May 24, 2013	Substantially Equivalent	Greatbatch Medical
K121404	SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM	May 03, 2013	Substantially Equivalent	ONSET MEDICAL CORPORATION
K123990	SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING	Apr 26, 2013	Substantially Equivalent	MEDTRONIC VASCULAR
K123430	MICROSLIDER TEARAWAY INTRODUCER SET	Apr 12, 2013	Substantially Equivalent	GALT MEDICAL CORP.
K123618	AXERA 2 ACCESS SYSTEM	Mar 24, 2013	Substantially Equivalent	ARSTASIS, INC.
K123974	PERCUTANEOUS INTRODUCER KIT	Feb 21, 2013	Substantially Equivalent	TELEFLEX, INC.
K123235	EQUAFLOW MULTIVALVE INFUSION CATHETER	Feb 14, 2013	Substantially Equivalent	COOK INCORPORATED
K122431	HEARTSPAN STEERABLE INTRODUCER KIT	Jan 29, 2013	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K123135	AXERA 2 ACCESS SYSTEM MODEL AXE200	Jan 28, 2013	Substantially Equivalent	ARSTASIS, INC.
K123334	REPROCESSED STEERABLE INTRODUCER	Jan 24, 2013	Substantially Equivalent	STRYKER SUSTAINABILITY SOLUTIONS, INC.
K122926	SUREFLEX STEERABLE GUIDING SHEATH KIT	Jan 24, 2013	Substantially Equivalent	BAYLIS MEDICAL CO., INC.
K122854	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	Jan 04, 2013	Substantially Equivalent	ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
K122960	STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO	Dec 13, 2012	Substantially Equivalent	Oscor Inc.
K122958	DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY	Dec 13, 2012	Substantially Equivalent	Oscor Inc.
K122980	GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ	Dec 11, 2012	Substantially Equivalent	Terumo Medical Corporation
K121234	GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING	Nov 20, 2012	Substantially Equivalent	W. L. GORE & ASSOCIATES, INC.
K120617	PTFE SUPER SHEATH INTRODUCER	Nov 19, 2012	Substantially Equivalent	MARTECH MEDICAL PRODUCTS
K121504	SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS	Sep 27, 2012	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K122084	INTRODUCER SET, MODEL ADELANTE-S SERIES	Aug 29, 2012	Substantially Equivalent	Oscor Inc.
K111603	LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM	Aug 23, 2012	Substantially Equivalent	EP DYNAMICS, INC.
K121185	EDWARDS PERCUTANEOUS SHEATH INTRODUCER	Aug 22, 2012	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K122190	PRELUDE 7F SHORT SHEATH INTRODUCER	Aug 17, 2012	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K120158	CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS	Aug 14, 2012	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K113849	HQS INTRODUCER	Jul 31, 2012	Substantially Equivalent	ALSEAL
K121748	THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL	Jul 27, 2012	Substantially Equivalent	ACCESS SCIENTIFIC, INC.
K120459	STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO	Jun 29, 2012	Substantially Equivalent	Oscor Inc.
K121521	AXERA ACCESS SYSTEM	Jun 21, 2012	Substantially Equivalent	ARSTASIS, INC.
K120428	GORE DRYSEAL SHEATH	Apr 20, 2012	Substantially Equivalent	W. L. GORE & ASSOCIATES, INC.
K112398	TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT	Apr 12, 2012	Substantially Equivalent	GALT MEDICAL
K112887	UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR	Mar 21, 2012	Substantially Equivalent	UPSTREAM PERIPHERAL TECHNOLOGIES
K120212	AFX INTRODUCER SYSTEM	Feb 09, 2012	Substantially Equivalent	ENDOLOGIX, INC.
K112407	SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS	Feb 09, 2012	Substantially Equivalent	SMITHS MEDICAL MD, INC.
K113196	VASCULAR SONO	Feb 06, 2012	Substantially Equivalent	PAJUNK GMBH MEDIZINTECHNOLOGIE
K110051	RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT	Feb 02, 2012	Substantially Equivalent	Greatbatch Medical
K112554	TRANSRADIAL ARTERY ACCESS DEVICES	Nov 18, 2011	Substantially Equivalent	Teleflex Medical, Inc.
K102925	NEXGEN EXPANDABLE CATHETER	Nov 10, 2011	Substantially Equivalent	NEXGEN MEDICAL SYSTEMS, INC.
K113110	AXERA ACCESS SYSTEM	Nov 09, 2011	Substantially Equivalent	ARSTASIS, INC.
K111606	PINNACLE PRECISION ACCESS SYSTEM	Oct 03, 2011	Substantially Equivalent	TERUMO MEDICAL CORP.
K111943	AGILLS PF DELIVERY SYSTEM	Sep 29, 2011	Substantially Equivalent	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
K111417	THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER	Jul 15, 2011	Substantially Equivalent	ACCESS SCIENTIFIC, INC.
K111747	ENDOLOGIX AFX INTRODUCER SYSTEM	Jul 12, 2011	Substantially Equivalent	ENDOLOGIX, INC.
K111138	THE PICC WAND (R) PEELABLE SAFETY INTRODUCER	Jun 22, 2011	Substantially Equivalent	ACCESS SCIENTIFIC, INC.
K111092	ENGAGE/ENGAGE TR INTRODUCERS	Jun 09, 2011	Substantially Equivalent	ST. JUDE MEDICAL
K110090	AFX INTRODUCER SYSTEM	May 26, 2011	Substantially Equivalent	ENDOLOGIX, INC.
K110450	AGILIS NXT STEERABLE INTRODUCER	May 10, 2011	Substantially Equivalent	ST. JUDE MEDICAL
K103083	AGILIS ES STEERABLE INTRODUCER	Apr 08, 2011	Substantially Equivalent	ST. JUDE MEDICAL
K102948	TORFLEX TRANSSEPTAL GUIDING SHEATH	Apr 01, 2011	Substantially Equivalent	BAYLIS MEDICAL CO., INC.
K101422	THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER	Mar 22, 2011	Substantially Equivalent	ACCESS SCIENTIFIC, INC.
K100799	FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815	Feb 25, 2011	Substantially Equivalent	CONTRACT MEDICAL INTL. GMBH
K103143	ARSTASIS ONE LATCHWIRE ACCESS SYSTEM	Feb 02, 2011	Substantially Equivalent	ARSTASIS, INC.
K101604	VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V	Jan 24, 2011	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K101784	MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX	Nov 26, 2010	Substantially Equivalent	Greatbatch Medical
K102540	PTFE PORTABLE INTRODUCER	Nov 16, 2010	Substantially Equivalent	Greatbatch Medical
K101497	DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY	Oct 20, 2010	Substantially Equivalent	Oscor Inc.
K102728	ARSTASIS ACCESS SYSTEM	Oct 07, 2010	Substantially Equivalent	ARSTASIS, INC.
K101883	6F ENGAGE/ENGAGE TR INTRODUCER	Sep 07, 2010	Substantially Equivalent	ST. JUDE MEDICAL
K101150	PICC WAND PEELABLE SAFETY INTRODUCER	Aug 13, 2010	Substantially Equivalent	ACCESS SCIENTIFIC, INC.
K100819	THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER	Aug 02, 2010	Substantially Equivalent	ONSET MEDICAL CORPORATION
K102008	GLIDESHEATH	Jul 21, 2010	Substantially Equivalent	TERUMO MEDICAL CORP.
K093877	RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26	Jul 01, 2010	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K101399	COAXIAL INTRODUCER SET	Jun 17, 2010	Substantially Equivalent	MARTECH MEDICAL PRODUCTS
K092097	A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH	May 06, 2010	Substantially Equivalent	A.B. KORKOR MEDICAL, INC.
K100615	ARSTASIS ACCESS SYSTEM	Mar 30, 2010	Substantially Equivalent	ARSTASIS, INC.
K093791	GORE DRYSEAL SHEATH	Mar 22, 2010	Substantially Equivalent	W.L. GORE & ASSOCIATES,INC
K093232	OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER	Mar 15, 2010	Substantially Equivalent	Greatbatch Medical
K091006	ITG VASCULAR ACCESS SYSTEM, MODEL 300	Feb 25, 2010	Substantially Equivalent	ARSTASIS, INC.
K093026	FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER	Feb 24, 2010	Substantially Equivalent	FOOTPRINT MEDICAL
K093022	THE PICC WAND PEELABLE SAFETY INTRODUCER	Jan 20, 2010	Substantially Equivalent	ACCESS SCIENTIFIC, INC.
K091954	MICRO-STICK SET	Jan 08, 2010	Substantially Equivalent	MEDCOMP
K091367	GDS-DCS	Nov 05, 2009	Substantially Equivalent	GUIDED DELIVERY SYSTEMS
K093130	ENGAGE TR INTRODUCER	Nov 04, 2009	Substantially Equivalent	ST. JUDE MEDICAL
K093023	PTFE PEELABLE INTRODUCER	Oct 29, 2009	Substantially Equivalent	Greatbatch Medical
K092575	ENGAGE/ENGAGE TR	Oct 08, 2009	Substantially Equivalent	ST. JUDE MEDICAL
K092014	SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER	Oct 08, 2009	Substantially Equivalent	ONSET MEDICAL CORPORATION
K090394	VALVED TEARWAY INTRODUCER	Sep 01, 2009	Substantially Equivalent	MEDCOMP
K090867	AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002	Jul 30, 2009	Substantially Equivalent	EP DYNAMICS, INC.
K090114	MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S	Jun 04, 2009	Substantially Equivalent	Oscor Inc.
K091329	PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH	May 29, 2009	Substantially Equivalent	TERUMO MEDICAL CORP.
K091137	ULTIMUM/ENGAGE/ENGAGE TR	Apr 22, 2009	Substantially Equivalent	ST. JUDE MEDICAL
K090999	BIOCARDIA MORPH SHEATH GUIDE	Apr 15, 2009	Substantially Equivalent	BIOCARDIA, INC.
K090372	THE WAND MICROACCESS SAFETY INTRODUCER	Mar 30, 2009	Substantially Equivalent	ACCESS SCIENTIFIC, INC.
K083855	MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59	Feb 17, 2009	Substantially Equivalent	ACUMEN MEDICAL, INC.
K083269	CROSSOVER	Feb 03, 2009	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K083402	AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323	Dec 15, 2008	Substantially Equivalent	ST. JUDE MEDICAL
K081645	AGILIS NXT STEERABLE INTRODUCER, MODEL G408324	Dec 09, 2008	Substantially Equivalent	ST. JUDE MEDICAL
K082580	SPECTRA GUIDEWIRE INTRODUCER NEEDLE	Dec 08, 2008	Substantially Equivalent	SPECTRA MEDICAL DEVICES, INC.
K081697	THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006	Dec 04, 2008	Substantially Equivalent	ACCESS SCIENTIFIC, INC.
K083083	AGILIS NXT STEERABLE INTRODUCER	Nov 06, 2008	Substantially Equivalent	ST. JUDE MEDICAL
K082847	PINNACLE ROII INTRODUCER SHEATH	Oct 29, 2008	Substantially Equivalent	TERUMO MEDICAL CORP.
K082063	PRELUDE SHORT SHEATH INTRODUCER	Oct 15, 2008	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K082644	GLIDESHEATH	Sep 18, 2008	Substantially Equivalent	TERUMO MEDICAL CORP.
K081394	PTFE INTERLOCK PEELABLE INTRODUCERS	Sep 15, 2008	Substantially Equivalent	ENPATH MEDICAL, INC.
K082356	GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE	Aug 28, 2008	Substantially Equivalent	W. L. GORE & ASSOCIATES, INC.
K081045	DESTINATION RENAL GUIDING SHEATH	May 28, 2008	Substantially Equivalent	TERUMO MEDICAL CORP.
K081046	PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH	May 21, 2008	Substantially Equivalent	TERUMO MEDICAL CORP.
K081341	REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)	May 14, 2008	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K073434	BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER	Apr 01, 2008	Substantially Equivalent	BIPORE, INC.
K080500	MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7	Mar 13, 2008	Substantially Equivalent	ACUMEN MEDICAL, INC.
K080415	DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH	Mar 07, 2008	Substantially Equivalent	TERUMO MEDICAL CORP.
K072719	CONVOY ADVANCED DELIVERY SHEATH	Mar 07, 2008	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K073100	INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S	Nov 30, 2007	Substantially Equivalent	Oscor Inc.
K072248	VIAPEEL PEELABLE INTRODUCER	Nov 09, 2007	Substantially Equivalent	ENPATH MEDICAL, INC.
K072130	PTFE PEEL AWAY MICROINTRODUCER	Oct 31, 2007	Substantially Equivalent	INTROMED
K070865	EXPANDING VASCULAR SHEATH	Oct 23, 2007	Substantially Equivalent	APPLIED MEDICAL
K070816	PERIPHERAL GUIDING SHEATH	Sep 19, 2007	Substantially Equivalent	MICRUS DESIGN TECHNOLOGY, INC.
K063658	INTRAVASCULAR INTRODUCER SYSTEM	Sep 12, 2007	Substantially Equivalent	APPLIED MEDICAL RESOURCES CORP.
K071574	STIFFER COAXIAL MICRO-INTRODUCER KIT	Jul 05, 2007	Substantially Equivalent	ENPATH MEDICAL, INC.
K070417	ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984	Jun 05, 2007	Substantially Equivalent	ST. JUDE MEDICAL
K070396	MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45	May 22, 2007	Substantially Equivalent	ACUMEN MEDICAL, INC.
K070166	STRADA CAROTID GUIDING SHEATH	Apr 06, 2007	Substantially Equivalent	ST. JUDE MEDICAL
K070197	ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY	Feb 23, 2007	Substantially Equivalent	ACUMEN MEDICAL, INC.
K062852	BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870	Feb 23, 2007	Substantially Equivalent	ONSET MEDICAL CORPORATION
K063182	ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX	Dec 21, 2006	Substantially Equivalent	ENPATH MEDICAL, INC.
K062446	MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH	Oct 23, 2006	Substantially Equivalent	TERUMO MEDICAL CORP.
K062858	MODIFICATION TO GLIDESHEATH	Oct 20, 2006	Substantially Equivalent	TERUMO MEDICAL CORP.
K062145	MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90	Aug 23, 2006	Substantially Equivalent	ACUMEN MEDICAL, INC.
K061015	FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER	Aug 03, 2006	Substantially Equivalent	ST.JUDE MEDICAL
K053092	MEDCOMP VASCU-SHEATH II	Aug 01, 2006	Substantially Equivalent	MEDCOMP
K061363	AGILIS NXT STEERABLE INTRODUCER	Jul 12, 2006	Substantially Equivalent	ST. JUDE MEDICAL
K060902	STARCLOSE INTRODUCER SET MODEL- 1002	Jul 07, 2006	Substantially Equivalent	ABBOTT VASCULAR INC.
K060666	CAROTID ACCESS KIT	Jun 29, 2006	Substantially Equivalent	TERUMO MEDICAL CORP.
K053400	ACUMEN SINGLE-LUMEN DELIVERY SHEATH	Jun 19, 2006	Substantially Equivalent	ACUMEN MEDICAL, INC.
K060519	INTRODUCER ASSEMBLY WITH ROTATOR LOCK	May 05, 2006	Substantially Equivalent	TELEFLEX MEDICAL
K060190	SUPER SHEATH XL INTRODUCER SHEATH	Apr 04, 2006	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K051513	BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER	Dec 07, 2005	Substantially Equivalent	BIPORE, INC.
K052644	SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER	Dec 05, 2005	Substantially Equivalent	ST. JUDE MEDICAL
K051248	VYGON MICRO-ACCESS SAFETY INTRODUCER KIT	Oct 27, 2005	Substantially Equivalent	VYGON CORP.
K052185	DESTINATION CAROTID GUIDING SHEATH	Sep 06, 2005	Substantially Equivalent	TERUMO MEDICAL CORP.
K051515	MODIFIED ACUMEN SHEATH, MODEL TTW 10-65	Sep 01, 2005	Substantially Equivalent	ACUMEN MEDICAL, INC.
K051601	PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH	Aug 04, 2005	Substantially Equivalent	TERUMO MEDICAL CORP.
K051468	INNER-LOCK INTRODUCER SHEATH	Aug 04, 2005	Substantially Equivalent	REX MEDICAL
K051096	APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582	May 17, 2005	Substantially Equivalent	ST. JUDE MEDICAL, DAIG DIVISION, INC.
K043084	PREMERE DELIVERY SHEATH, MODEL PDS	May 02, 2005	Substantially Equivalent	VELOCIMED INC.
K050023	SECURELOC; ADVANCINTRODUCER	Feb 18, 2005	Substantially Equivalent	SPECIALIZED HEALTH PRODUCTS, INC.
K042308	SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019	Feb 17, 2005	Substantially Equivalent	FACILE MEDICAL, INC.
K043438	LARGE BORE SPLITTABLE INTRODUCER KIT	Feb 15, 2005	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K043525	CATHETER INTRODUCER	Feb 09, 2005	Substantially Equivalent	GALT MEDICAL CORP.
K050015	MODIFIED ACUMEN SHEATH, MODEL TTWO767	Feb 03, 2005	Substantially Equivalent	ACUMEN MEDICAL, INC.
K042623	AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304	Jan 27, 2005	Substantially Equivalent	ST. JUDE MEDICAL, DAIG DIVISION, INC.
K042399	MODIFICATION TO SHORT INTRODUCER SHEATH	Dec 17, 2004	Substantially Equivalent	REX MEDICAL LP
K041708	ENPATH SAFETY INTRODUCER	Nov 30, 2004	Substantially Equivalent	ENPATH MEDICAL INCORPORATED
K042376	ACUMEN SHEATH, MODEL TTW7807	Oct 26, 2004	Substantially Equivalent	ACUMEN MEDICAL, INC.
K041506	INTRAVASCULAR ACCESS INTRODUCER SHEATH	Oct 15, 2004	Substantially Equivalent	APPLIED MEDICAL RESOURCES CORP.
K042036	AIRGUARD VALVED INTRODUCER	Aug 23, 2004	Substantially Equivalent	C.R. BARD, INC.
K040728	ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT	Jun 18, 2004	Substantially Equivalent	ANGIODYNAMICS, INC.
K040713	MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM	Jun 01, 2004	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K040552	MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130	May 28, 2004	Substantially Equivalent	CRYOCOR, INC.
K040029	SAFETYNET GUIDEWIRE INTRODUCER	Apr 05, 2004	Substantially Equivalent	INJECTIMED, INC.
K034025	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	Mar 26, 2004	Substantially Equivalent	NMT MEDICAL, INC.
K040150	MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER	Feb 18, 2004	Substantially Equivalent	MEDAMICUS, INC.
K033527	INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER	Feb 05, 2004	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K034061	MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH	Jan 30, 2004	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K033681	GLIDESHEATH	Dec 11, 2003	Substantially Equivalent	TERUMO CORP.
K031922	CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W	Oct 01, 2003	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K032569	SHORT INTRODUCER SHEATH	Sep 16, 2003	Substantially Equivalent	REX MEDICAL
K032404	SELDINGER SAFETY NEEDLE INTRODUCER	Sep 10, 2003	Substantially Equivalent	HDC CORP.
K030734	PATHWAY ACCESS SHEATH CATHETER	Sep 10, 2003	Substantially Equivalent	VERTELINK CORPORATION
K032073	GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE	Aug 13, 2003	Substantially Equivalent	W. L. GORE & ASSOCIATES, INC.
K031906	APEEL CS CATHETER DELIVERY SYSTEM	Jul 18, 2003	Substantially Equivalent	ST. JUDE MEDICAL
K030135	SAFETY INTRODUCER NEEDLE	Jul 15, 2003	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K030944	EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL	Jun 20, 2003	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K031583	MODIFICATION TO IVS INTRODUCER SET, MODEL 1003	Jun 16, 2003	Substantially Equivalent	INTEGRATED VASCULAR SYSTEMS, INC.
K023937	COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM	May 27, 2003	Substantially Equivalent	COOK VASCULAR, INC.
K031087	EDWARDS INTRODUCER SHEATH	Apr 24, 2003	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K030905	MEDAMICUS FLOWGUARD PEELABLE INTRODUCER	Apr 09, 2003	Substantially Equivalent	MEDAMICUS, INC.
K030723	IVS INTRODUCER SET, MODEL 1003	Apr 03, 2003	Substantially Equivalent	INTEGRATED VASCULAR SYSTEMS, INC.
K022170	INNER-LOCK LOCKING INTRODUCER SHEATHS	Jan 21, 2003	Substantially Equivalent	REX MEDICAL
K022634	CO-AXIAL INTRODUCER NEEDLE	Nov 06, 2002	Substantially Equivalent	PROMEX, INC.
K023447	MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)	Oct 31, 2002	Substantially Equivalent	ST. JUDE MEDICAL
K022513	MEDCOMP VASCU-SHEATH INTRODUCER SET	Oct 25, 2002	Substantially Equivalent	MEDCOMP
K020964	NEICH NM ADVANCE CATHETER SHEATH INTRODUCER	Oct 11, 2002	Substantially Equivalent	NEICH MEDICAL(SHENZHEN)COMPANY, LTD.
K022003	TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305	Sep 13, 2002	Substantially Equivalent	MICRO THERAPEUTICS, INC.
K022689	MODIFICATION TO MEDAMICUS AXIA RSN	Aug 23, 2002	Substantially Equivalent	MEDAMICUS, INC.
K021723	SHEATH ADAPTER, MODEL SA-09847	Aug 08, 2002	Substantially Equivalent	ARROW INTL., INC.
K021094	INTROCAN SAFETY IV CATHETER	Jul 03, 2002	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K020834	BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I	Jun 12, 2002	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K021004	VALVED PEELABLE INTRODUCER	Jun 06, 2002	Substantially Equivalent	MEDAMICUS, INC.
K020563	MEDAMICUS AXIA RSN	May 21, 2002	Substantially Equivalent	MEDAMICUS, INC.
K010128	COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE	Apr 25, 2002	Substantially Equivalent	COOK VASCULAR, INC.
K014052	EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL	Mar 08, 2002	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K020090	MODIFICATION TO TRANSSEPTAL INTRODUCER SET	Feb 11, 2002	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K003889	ANCURE SHEATH MODEL # 40315, 40320, 40325	Jan 24, 2002	Substantially Equivalent	GUIDANT CARDIAC AND VASCULAR SURGERY
K012854	RENAL GUIDING SHEATH	Nov 21, 2001	Substantially Equivalent	TERUMO MEDICAL CORP.
K012812	CAROTID GUIDING SHEATH	Nov 14, 2001	Substantially Equivalent	TERUMO MEDICAL CORP.
K011761	MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT	Oct 31, 2001	Substantially Equivalent	ARROW INTL., INC.
K013202	MODIFICATION TO BRAIDED GUIDING INTRODUCER	Oct 23, 2001	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K013029	SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515	Oct 09, 2001	Substantially Equivalent	ST. JUDE MEDICAL
K010913	VYGON SPLIT CANNULA INTRODUCER	Sep 28, 2001	Substantially Equivalent	VYGON CORP.
K012922	ULTRAFLEX EV HEMOSTASIS INTRODUCER	Sep 25, 2001	Substantially Equivalent	ST. JUDE MEDICAL
K011790	MICROCRUISER PLUS INTRODUCER SET	Sep 05, 2001	Substantially Equivalent	MEDICAL DEVICE TECHNOLOGIES, INC.
K012489	MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10	Aug 30, 2001	Substantially Equivalent	APPRIVA MEDICAL, INC.
K004025	SPLITTABLE SHEATH INTRODUCER KIT	Jul 19, 2001	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K011085	GUIDEWIRE INTRODUCER SAFETY NEEDLE	Jul 09, 2001	Substantially Equivalent	MEDAMICUS, INC.
K004026	BRAIDED GUIDING INTRODUCER	Jul 09, 2001	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K002847	INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX	May 31, 2001	Substantially Equivalent	MAXXIM MEDICAL
K002973	EMBOL-X INTRODUCER, MODEL CF00200	Apr 26, 2001	Substantially Equivalent	EMBOL-X, INC.
K003731	SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE	Apr 10, 2001	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K002507	TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT	Mar 21, 2001	Substantially Equivalent	ARROW INTL., INC.
K002054	X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1	Feb 16, 2001	Substantially Equivalent	APPRIVA MEDICAL, INC.
K001985	INTRODEUCE DOUBLE LUMEN INTRODUCER	Jan 25, 2001	Substantially Equivalent	COOK, INC.
K003729	ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),	Jan 03, 2001	Substantially Equivalent	ST. JUDE MEDICAL
K000004	ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509	Nov 29, 2000	Substantially Equivalent	DAIG CORP.
K003424	PINNACLE R/O II OR RADIFOCUS INTRODUCER II	Nov 21, 2000	Substantially Equivalent	TERUMO MEDICAL CORP.
K002676	ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER	Oct 30, 2000	Substantially Equivalent	GUIDANT CARDIAC AND VASCULAR SURGERY
K001926	VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES	Sep 22, 2000	Substantially Equivalent	THORATEC LABORATORIES CORP.
K002365	DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET	Aug 25, 2000	Substantially Equivalent	DATASCOPE CORP.
K001135	6F & 7F INTRODUCING CATHETERS (MODIFICATION)	Jul 03, 2000	Substantially Equivalent	CORDIS CORP.
K000313	TEARAWAY INTRODUCER SHEATH	Jun 16, 2000	Substantially Equivalent	XENTEK MEDICAL, INC.
K001367	FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX	May 31, 2000	Substantially Equivalent	ST. JUDE MEDICAL, INC.
K992668	INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)	May 26, 2000	Substantially Equivalent	INNERDYNE, INC.
K001346	ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX	May 24, 2000	Substantially Equivalent	ST. JUDE MEDICAL, INC.
K994334	ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX	May 15, 2000	Substantially Equivalent	DAIG CORP.
K001139	PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M	May 10, 2000	Substantially Equivalent	BIOSENSE WEBSTER, INC.
K000824	PERCUTANEOUS INTRODUCER, MODEL 10383-XXX	Apr 13, 2000	Substantially Equivalent	MEDAMICUS, INC.
K993191	TFX MEDICAL INTRODUCER ASSEMBLY	Mar 24, 2000	Substantially Equivalent	TFX MEDICAL, INC.
K990975	IN-LINE HEMOSTASIS VALVE	Mar 15, 2000	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K994252	INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE	Jan 04, 2000	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K991647	TFX MEDICAL INTRODUCER KIT	Jan 04, 2000	Substantially Equivalent	TFX MEDICAL GROUP
K992309	INTRODUCER SHEATH, VESSEL DILATOR	Oct 07, 1999	Unknown	BOSTON SCIENTIFIC CORP.
K983940	EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR	Jul 15, 1999	Substantially Equivalent	ADAM SPENCE CORP.
K990705	MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET	Jun 28, 1999	Substantially Equivalent	MEDAMICUS, INC.
K983039	EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF	May 07, 1999	Unknown	SCHNEIDER/NAMIC
K984062	SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229	Mar 24, 1999	Substantially Equivalent	DIAG CORP.
K984260	PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)	Jan 26, 1999	Substantially Equivalent	TERUMO MEDICAL CORP.
K984500	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	Dec 23, 1998	Substantially Equivalent	CORDIS CORP.
K982797	BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB	Nov 30, 1998	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K981909	BAXTER HEMOSTASIS VALVE INTRODUCERS	Nov 24, 1998	Substantially Equivalent	BAXTER EDWARDS
K983023	MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	Oct 01, 1998	Substantially Equivalent	CORDIS CORP.
K982187	FAST-CATH INTRA-CARDIAC INTRODUCER	Sep 16, 1998	Substantially Equivalent	DAIG CORP.
K980578	INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)	Sep 11, 1998	Substantially Equivalent	INNERDYNE, INC.
K982740	CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S	Aug 28, 1998	Substantially Equivalent	CORDIS WEBSTER, INC.
K981782	LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM	Aug 12, 1998	Substantially Equivalent	ARROW INTL., INC.
K980504	EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET	Aug 07, 1998	Substantially Equivalent	SCHNEIDER/NAMIC
K973840	FAST-CATH (TM) INTRA-CARDIAC INTRODUCER	May 21, 1998	Substantially Equivalent	DAIG CORP.
K970229	ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET	Feb 13, 1998	Substantially Equivalent	ARROW INTL., INC.
K974448	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	Feb 06, 1998	Substantially Equivalent	CORDIS CORP.
K973007	DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER	Nov 06, 1997	Substantially Equivalent	DATASCOPE CORP.
K970264	CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM	Oct 28, 1997	Substantially Equivalent	CORDIS WEBSTER, INC.
K972684	INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM	Oct 10, 1997	Substantially Equivalent	INNERDYNE, INC.
K972570	HEARTPORT INTRODUCER SHEATH	Oct 01, 1997	Substantially Equivalent	HEARTPORT, INC.
K965167	PERCUTANEOUS VENOUS INTRODUCER 10264	Jul 25, 1997	Substantially Equivalent	MEDAMICUS, INC.
K971608	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	Jul 21, 1997	Substantially Equivalent	CORDIS CORP.
K964518	FAST-CATH TRANSSEPTAL CATHETER INTRODUCER	May 14, 1997	Substantially Equivalent	DAIG CORP.
K964814	BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER	May 07, 1997	Substantially Equivalent	BIPORE, INC.
K964034	TRANSJUGULAR ACCESS SET	May 06, 1997	Substantially Equivalent	ANGIODYNAMICS, INC.
K963886	EVS	Apr 24, 1997	Substantially Equivalent	APPLIED MEDICAL RESOURCES
K970201	GSI CANNULA WITH INTRODUCER	Apr 21, 1997	Substantially Equivalent	GENERAL SURGICAL INNOVATIONS
K962978	CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM	Jan 07, 1997	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.
K961780	HEMODIALYSIS INTRODUCER SET	Dec 24, 1996	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K962180	CATH SEAL	Nov 07, 1996	Substantially Equivalent	UNIVERSAL MEDICAL INSTRUMENT CORP.
K962746	CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT	Oct 11, 1996	Substantially Equivalent	CORDIS CORP.
K961745	BRAUN PERCUTANEOUS INTRODUCER SET	Sep 17, 1996	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K961466	PERCUTANEOUS INTRODUCER SET	Sep 12, 1996	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K960445	INPUT TUOHY-BORST LOCKING DEVICE	Aug 12, 1996	Substantially Equivalent	C.R. BARD, INC.
K960625	SPREADABLE SHEATH INTRODUCER SET	Aug 08, 1996	Substantially Equivalent	NEOSTAR MEDICAL TECHNOLOGIES, INC.
K960200	INTROSTAT LEAD INTRODUCER	Jul 02, 1996	Substantially Equivalent	MSI, INC.
K961513	PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET	May 13, 1996	Substantially Equivalent	EP MEDSYSTEMS
K961135	INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)	Apr 30, 1996	Substantially Equivalent	C.R. BARD, INC.
K960406	BRAUN HEMOSTASIS INTRODUCERS	Apr 12, 1996	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K954906	FIRST PICC INTRODUCER CATHETER	Apr 08, 1996	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K955820	BRAUN HEMOSTASIS INTRODUCERS	Mar 25, 1996	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K955785	TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET	Mar 12, 1996	Substantially Equivalent	C.R. BARD, INC.
K960310	EPIC INTRODUCER SHEATH	Feb 07, 1996	Substantially Equivalent	NORTH AMERICAN INSTRUMENT CORP.
K954595	CORDIS BRITE TIP SHEATH INTRODUCER	Dec 28, 1995	Substantially Equivalent	CORDIS CORP.
K942977	NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE	Dec 28, 1995	Substantially Equivalent	NOVOSTE CORP.
K954317	DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS	Nov 28, 1995	Substantially Equivalent	DAIG CORP.
K954234	RADIFOCUS INTRODUCER II KIT	Nov 27, 1995	Substantially Equivalent	TERUMO MEDICAL CORP.
K952828	MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM	Aug 18, 1995	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K940092	USCI INPUT INTRODUCER SET	Aug 10, 1995	Substantially Equivalent	USCI, DIV. C.R. BARD, INC.
K950155	RAPID-TRAK(TM) INTRODUCER SHEATH	Aug 02, 1995	Substantially Equivalent	CARDIO VASCULAR CONCEPTS, INC.
K951313	MEDAMICUS PERCUTANEOUS INTRODUCER	Jun 27, 1995	Substantially Equivalent	MEDAMICUS, INC.
K945524	CORDIS INTRODUCING CATHETER	Apr 26, 1995	Substantially Equivalent	CORDIS CORP.
K945616	CORDIS AVANTI CATHETER SHEATH INTRODUCER	Mar 29, 1995	Substantially Equivalent	CORDIS CORP.
K945396	FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET	Mar 13, 1995	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K933522	INTRODUCER NEEDLE (SEVERAL SIZES)	Feb 21, 1995	Substantially Equivalent	MEDIZIV MEDICAL PRODUCTS 1987 LTD.
K940079	ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903	Nov 30, 1994	Substantially Equivalent	ARROW INTL., INC.
K942191	URESIL DILATOR	Sep 21, 1994	Substantially Equivalent	URESIL CORP.
K944107	VIP PLUS PERCUTANEOUS INTRODUCER	Sep 14, 1994	Substantially Equivalent	MEDAMICUS, INC.
K941428	EXACTA PERCUTANEOUS INTRODUCER SHEATH	Jul 06, 1994	Substantially Equivalent	OHMEDA MEDICAL
K935077	CATH-SEAL	Jun 07, 1994	Substantially Equivalent	UNIVERSAL MEDICAL INSTRUMENT CORP.
K934624	ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE	Apr 13, 1994	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K930808	PROTECTOR INTRODUCER SHEATH	Mar 15, 1994	Substantially Equivalent	BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
K934901	TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE	Jan 21, 1994	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K934285	CATHETER INTRODUCER MODIFICATION	Nov 24, 1993	Substantially Equivalent	DAIG CORP.
K932370	REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET	Nov 09, 1993	Substantially Equivalent	REMINGTON MEDICAL, INC.
K932323	PERCUTANEOUS INTRODUCER	Nov 09, 1993	Substantially Equivalent	MEDAMICUS, INC.
K931743	BURRON CARDIOVASCULAR ANGESTAT(TM)	Nov 02, 1993	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K931489	INTHERM RADIALLY EXPANDING DILATING INTRODUCER	Oct 15, 1993	Substantially Equivalent	INNERDYNE MEDICAL, INC.
K931587	MULTI-PORT Y INTRODUCER SET	Oct 06, 1993	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K931218	INTROPEEL V	Sep 22, 1993	Substantially Equivalent	MENLO CARE, INC.
K930801	INTROPEEL	Sep 22, 1993	Substantially Equivalent	MENLO CARE, INC.
K930194	HEMOSTASIS VALVE AND TUBING SET	Sep 22, 1993	Substantially Equivalent	OPTICON MEDICAL, INC.
K931662	LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES	Aug 31, 1993	Substantially Equivalent	PACE MEDICAL
K932733	CORDIS CATHETER SHEATH INTRODUCER	Aug 26, 1993	Substantially Equivalent	CORDIS CORP.
K930057	ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET	Aug 06, 1993	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K925633	BALT INTRODUCER	Jun 25, 1993	Substantially Equivalent	TARGET THERAPEUTICS
K931102	CORDIS NIHON CATHETER SHEATH INTRODUCER	May 27, 1993	Substantially Equivalent	CORDIS CORP.
K926340	NEW LEAD INTRODUCER KITS, VARIOUS MODELS	May 27, 1993	Substantially Equivalent	TELECTRONICS PACING SYSTEMS, INC.
K924607	ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET	Apr 22, 1993	Substantially Equivalent	ARROW INTL., INC.
K924456	LONG LENGTH PERCUTANEOUS INTRODUCER SET	Mar 22, 1993	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K923603	INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION	Mar 08, 1993	Substantially Equivalent	KONTRON INSTRUMENTS, INC.
K924562	CATHETER INTRODUCER	Feb 25, 1993	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K923681	EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI	Jan 21, 1993	Substantially Equivalent	EXONIX RESEARCH CORP.
K924491	INTRODUCER, PERCUTANEOUS -- MODIFICATION	Nov 18, 1992	Substantially Equivalent	MEDAMICUS, INC.
K920908	OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1	Oct 06, 1992	Substantially Equivalent	Teleflex Medical, Inc.
K920907	OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO	Oct 06, 1992	Substantially Equivalent	Teleflex Medical, Inc.
K912664	TEC ROTATING DUAL HEMOVALVE	Aug 24, 1992	Substantially Equivalent	INTENSIVE TECHNOLOGY, INC.
K920528	CATHETER INTRODUCER	Aug 12, 1992	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K915078	MORSE HEMOSTATIC CATHETER INTRODUCER SET	Jun 10, 1992	Substantially Equivalent	NORTH AMERICAN INSTRUMENT CORP.
K920998	GORE TUNNELER, MODIFICATION	Jun 03, 1992	Substantially Equivalent	W.L. GORE & ASSOCIATES,INC
K920779	FAST-CATH HEMOSTASIS INTRODUCER	Jun 03, 1992	Substantially Equivalent	DAIG CORP.
K915625	INTRODUCER CATHETER	Jun 03, 1992	Substantially Equivalent	INTERVENTIONAL THERAPEUTICS CORP.
K920327	DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER	Apr 16, 1992	Substantially Equivalent	DAIG CORP.
K920251	USCI HEMAQUET XT INTRODUCER	Mar 18, 1992	Substantially Equivalent	C.R. BARD, INC.
K915421	GUIDEWIRE INTRODUCER SET	Feb 27, 1992	Substantially Equivalent	B. BRAUN OF AMERICA, INC.
K915553	USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING	Feb 21, 1992	Substantially Equivalent	C.R. BARD, INC.
K915167	GESCO PER-Q-CATH CATHETER INTRODUCER	Jan 27, 1992	Substantially Equivalent	GESCO INTL., INC.
K914330	SOS BLOODLESS NEEDLE	Dec 20, 1991	Substantially Equivalent	E-Z-EM, INC.
K911883	DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER	Nov 29, 1991	Substantially Equivalent	DIAG CORP.
K914352	CORDIS OBTURATOR	Nov 22, 1991	Substantially Equivalent	CORDIS CORP.
K914046	THE BIG EASY Y-ADAPTER	Nov 08, 1991	Substantially Equivalent	MICROVENA CORP.
K914090	DAIG FAST CATH(TM) INTRODUCER, MODIFICATION	Oct 28, 1991	Substantially Equivalent	DAIG CORP.
K913801	CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL	Oct 16, 1991	Substantially Equivalent	CORDIS CORP.
K912961	MORSE VASCULAR INTRODUCER SET	Sep 11, 1991	Substantially Equivalent	NORTH AMERICAN INSTRUMENT CORP.
K911794	CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE	Jul 19, 1991	Substantially Equivalent	CORDIS CORP.
K911678	ROTATING HEMOSTATIC VALVE	Jul 12, 1991	Substantially Equivalent	DEVICES FOR VASCULAR INTERVENTION, INC.
K911236	MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS	Jun 18, 1991	Substantially Equivalent	MEDTRONIC VASCULAR
K910933	OLYMPUS ANGIOSCOPY IRRIGATION SHEATH	Jun 03, 1991	Substantially Equivalent	OLYMPUS CORP.
K910688	CORDIS PEEL-AWAY INSERTION TOOL	May 16, 1991	Substantially Equivalent	CORDIS CORP.
K910861	PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK	May 07, 1991	Substantially Equivalent	DAIG CORP.
K904475	ENTREE SHEATH INTRODUCER SYSTEM	Apr 01, 1991	Substantially Equivalent	CORDIS CORP.
K903463	IVT INTRODUCER SHEATH	Jan 03, 1991	Substantially Equivalent	INTENSIVE TECHNOLOGY, INC.
K903410	BIO-MEDICUS CANNULA INTRODUCER	Oct 31, 1990	Substantially Equivalent	BIO MEDICUS, INC.
K903530	PERCUTANEOUS INTRODUCERS	Oct 22, 1990	Substantially Equivalent	DAVOL, INC.
K903840	GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY	Oct 16, 1990	Substantially Equivalent	INTEC MEDICAL, INC.
K902932	DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL	Oct 16, 1990	Substantially Equivalent	DATASCOPE CORP.
K903906	PERCUTANEOUS CATHETER INTRODUCER KIT	Sep 26, 1990	Substantially Equivalent	INTEC MEDICAL, INC.
K902275	PERCUTANEOUS INTRODUCER SET	Sep 26, 1990	Substantially Equivalent	THOMAS MEDICAL PRODUCTS, INC.
K902477	WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET	Aug 24, 1990	Substantially Equivalent	MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE
K903442	ARIES TAPERSEAL(TM) SHEATH	Aug 23, 1990	Substantially Equivalent	ARIES MEDICAL, INC.
K900658	INTRODUCER, PERCUTANEOUS	Aug 23, 1990	Substantially Equivalent	NOVOSTE PUERTO RICO, INC.
K900515	MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)	Aug 23, 1990	Substantially Equivalent	MEDTRONIC VASCULAR
K900756	ITC INTRODUCER CATHETER	Aug 08, 1990	Substantially Equivalent	INTERVENTIONAL THERAPEUTICS CORP.
K902251	SUBCLAVIAN INTRODUCER SET	Jul 31, 1990	Substantially Equivalent	INFUSAID CORP.
K901391	DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER	Jun 26, 1990	Substantially Equivalent	DATASCOPE CORP.
K901452	USCI(R) ACCESS(TM) INTRODUCER SET	May 22, 1990	Substantially Equivalent	C.R. BARD, INC.
K895580	Y-ADAPTER W/THOUY BORST	Apr 30, 1990	Substantially Equivalent	ANGEION CORP.
K897041	HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS	Mar 16, 1990	Substantially Equivalent	C.R. BARD, INC.
K895044	DUAL GUIDE INTRODUCER CATHETER	Feb 26, 1990	Substantially Equivalent	COOK, INC.
K891121	MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM	Dec 05, 1989	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K894446	ANGEION HEMOSTASIS VALVE INTRODUCER	Nov 30, 1989	Substantially Equivalent	ANGEION CORP.
K895214	HEMOSTASIS VALVE	Nov 14, 1989	Substantially Equivalent	APPLIED VASCULAR DEVICES, INC.
K894445	MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE	Oct 02, 1989	Substantially Equivalent	MALLINCKROOT, INC.
K894157	OBTURATOR	Sep 28, 1989	Substantially Equivalent	ARGON MEDICAL CORP.
K894343	DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO	Sep 26, 1989	Substantially Equivalent	DAIG CORP.
K890766	CATHETER INTRODUCER SHEATH	Sep 18, 1989	Substantially Equivalent	APPLIED VASCULAR DEVICES, INC.
K894431	MODIFIED LABELING TO PERMANENT LEAD INTRODUCER	Sep 06, 1989	Substantially Equivalent	DAIG CORP.
K894430	MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY	Aug 09, 1989	Substantially Equivalent	DAIG CORP.
K885179	INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD	Aug 09, 1989	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K893658	PERCUTANEOUS INTRODUCER	Aug 03, 1989	Substantially Equivalent	MEDAMICUS, INC.
K891022	INTRODUCER FOR PTCA GUIDING CATHETERS	May 19, 1989	Substantially Equivalent	ARGON MEDICAL CORP.
K890277	HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT	Mar 10, 1989	Substantially Equivalent	OSCOR MEDICAL CORP.
K884494	DAIG OBTURATOR, CATHETER INTRODUCER	Feb 22, 1989	Substantially Equivalent	DAIG CORP.
K884159	SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT	Feb 22, 1989	Substantially Equivalent	MALLINCKROOT, INC.
K884104	USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR	Dec 21, 1988	Substantially Equivalent	C.R. BARD, INC.
K882657	HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT	Dec 13, 1988	Substantially Equivalent	HARBOR MEDICAL DEVICES, INC.
K883933	INTRODUCING CATHETER	Dec 02, 1988	Substantially Equivalent	DEVICES FOR VASCULAR INTERVENTION, INC.
K881825	MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH	Sep 28, 1988	Substantially Equivalent	SPECTRAMED, INC.
K882221	OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE	Aug 12, 1988	Substantially Equivalent	ARGON MEDICAL CORP.
K875158	ACS FUNNEL INTRODUCER	May 31, 1988	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K873100	OLYMPUS ANGIOSCOPY SHEATH	Feb 29, 1988	Substantially Equivalent	OLYMPUS CORP.
K873195	SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO	Dec 15, 1987	Substantially Equivalent	ANGIOMEDICS, INC.
K873727	PULL-APART INTRODUCER (SHEATH)	Oct 07, 1987	Substantially Equivalent	QUINTON, INC.
K873394	OVAL PULL-APART SHEATH/DILATOR	Sep 30, 1987	Substantially Equivalent	QUINTON, INC.
K871153	CATHETER INTRODUCER	Jun 24, 1987	Substantially Equivalent	ANGEION CORP.
K871208	UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M	Jun 05, 1987	Substantially Equivalent	PACESETTER SYSTEMS
K870542	VASCATH VASCULAR CATHETER PLACEMENT KIT	Apr 27, 1987	Substantially Equivalent	TITAN MEDICAL, INC.
K871140	ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER	Apr 22, 1987	Substantially Equivalent	ARIES MEDICAL, INC.
K871132	PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS	Apr 20, 1987	Substantially Equivalent	DELTEC SYSTEMS, INC.
K870907	INTRODUCER, PERCUTANEOUS	Apr 09, 1987	Substantially Equivalent	MEDFUSION SYSTEMS, INC.
K870374	PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK	Mar 18, 1987	Substantially Equivalent	DAIG CORP.
K870189	ARIES TAPERED SHEATH	Mar 16, 1987	Substantially Equivalent	ARIES MEDICAL, INC.
K864705	MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH	Feb 13, 1987	Substantially Equivalent	QUINTON, INC.
K864352	MODIFIED PEEL-AWAY INTRODUCER SET LINE	Jan 06, 1987	Substantially Equivalent	QUINTON, INC.
K863917	CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.	Jan 06, 1987	Substantially Equivalent	CARDIO-VASCULAR INNOVATIONS, INC.
K863139	TERUMO RADIFOCUS INTRODUCER KIT	Oct 10, 1986	Substantially Equivalent	TERUMO MEDICAL CORP.
K861984	UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO	Aug 05, 1986	Substantially Equivalent	UNIVERSAL MEDICAL INSTRUMENT CORP.
K861238	ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV	Jul 16, 1986	Substantially Equivalent	ANGIOMEDICS, INC.
K861951	MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER	Jun 19, 1986	Substantially Equivalent	TELEFLEX, INC.
K860307	PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET	May 20, 1986	Substantially Equivalent	TELEFLEX, INC.
K861082	CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST	May 05, 1986	Substantially Equivalent	CORDIS CORP.
K860898	SUBCLAVIAN INTRODUCER SET	Apr 29, 1986	Substantially Equivalent	INFUSAID CORP.
K860958	CATHETER INTRODUCER	Apr 23, 1986	Substantially Equivalent	TARGET THERAPEUTICS
K855061	CURITY PERCUTANEOUS CATHETER INSERTION KIT	Apr 16, 1986	Substantially Equivalent	THE KENDAL CO.
K855060	CURITY PERCUTANEOUS CATHETER INSERTION TRAY	Apr 16, 1986	Substantially Equivalent	THE KENDAL CO.
K854941	PMS PERCUTANEOUS PUNCTURE NEEDLE	Apr 16, 1986	Substantially Equivalent	PROFESSIONAL MEDICAL SERVICES
K860432	PERCUTANEOUS INTRODUCER KIT	Mar 31, 1986	Substantially Equivalent	CORMED, INC., SUB. C.R.BARD, INC.
K854831	VALVOKIT	Mar 31, 1986	Substantially Equivalent	NOVAMED PRODUCTS, INC.
K855126	CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES	Feb 26, 1986	Substantially Equivalent	CORDIS CORP.
K854559	MEDTRONIC PERMANENT LEAD INTRODUCER	Dec 24, 1985	Substantially Equivalent	MEDTRONIC VASCULAR
K853072	CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90	Dec 09, 1985	Substantially Equivalent	CAMINO LABORATORIES, INC.
K853100	COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT	Sep 25, 1985	Substantially Equivalent	COBE LABORATORIES, INC.
K852880	PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET)	Aug 29, 1985	Substantially Equivalent	ARGON MEDICAL CORP.
K851947	PTCA GUIDING CATHETER	Aug 16, 1985	Substantially Equivalent	CORDIS CORP.
K852918	SLIM ART J. BIP PACING LEAD USING POLY #030-2821	Jul 29, 1985	Substantially Equivalent	TELECTRONICS, INC.
K852917	SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283	Jul 29, 1985	Substantially Equivalent	TELECTRONICS, INC.
K852916	SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284	Jul 29, 1985	Substantially Equivalent	TELECTRONICS, INC.
K845037	PERCUTANEOUS ANGIOGRAPHIC NEEDLES	Jun 21, 1985	Substantially Equivalent	MALLINCKRODT CRITICAL CARE
K844593	CARDIOVASCULAR CUSTOM SURGICAL KIT	Jun 21, 1985	Substantially Equivalent	XANMED CORP.
K851141	TELEFLEX MEDICAL INTRODUCER CATHETER	May 16, 1985	Substantially Equivalent	Teleflex Medical, Inc.
K844840	DESERET INTRODUCER SET	May 16, 1985	Substantially Equivalent	PARKE-DAVIS CO.
K851078	HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER	Apr 19, 1985	Substantially Equivalent	HDC CORP.
K850820	PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID	Apr 10, 1985	Substantially Equivalent	UNIVERSAL MEDICAL INSTRUMENT CORP.
K844693	PEEL-AWAY INTRODUCER SET	Mar 06, 1985	Substantially Equivalent	QUINTON, INC.
K843798	MEADOX SURGIMED A/S CATHETER SHEATH SYS	Dec 27, 1984	Substantially Equivalent	MEADOX SURGIMED, INC.
K843118	CANNULA INTRODUCER	Nov 13, 1984	Substantially Equivalent	CARDIOVASCULAR RESEARCH, INC.
K843642	SUBCLAVIAN LEAD INTRODUCER SYS	Oct 23, 1984	Substantially Equivalent	XANMED CORP.
K843641	CATHETER INTRODUCER SYSTEM	Oct 23, 1984	Substantially Equivalent	XANMED CORP.
K843719	SINGLE WALL INTRODUCER NEEDLE	Oct 18, 1984	Substantially Equivalent	OCEAN MEDICAL PRODUCTS, LTD.
K843500	FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN	Oct 18, 1984	Substantially Equivalent	CARDIO-VASCULAR INNOVATIONS, INC.
K842780	MEDTRONIC 6210 PERMANENT LEAD INTRODUC	Aug 03, 1984	Substantially Equivalent	MEDTRONIC VASCULAR
K842259	PCI W/CATH-SEAL SIDE FLOW FITTING	Aug 01, 1984	Substantially Equivalent	UNIVERSAL MEDICAL INSTRUMENT CORP.
K842004	PERCUTANEOUS CATHETER INTRODUCER SET	Jul 13, 1984	Substantially Equivalent	ARIES MEDICAL, INC.
K840455	EMERGENCY INFUSION DEVICE	May 23, 1984	Substantially Equivalent	ARROW INTL., INC.
K840923	ANGIOGRAPHY NEEDLE W/WO CONNECTION	Apr 17, 1984	Substantially Equivalent	DLP, INC.
K834074	PERCUTANEOUS SHEATH INTRODUCER TRAY	Mar 19, 1984	Substantially Equivalent	PACKAGING TECHNOLOGIES, INC.
K831751	LEAD INTRODUCER SETS-EB-S8 & EB-S12	Oct 20, 1983	Substantially Equivalent	Oscor Inc.
K830829	CORONARY GUIDING CATHETER	Apr 28, 1983	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K830813	FRENCH PERCUTANEOUS SHEATH INTRODUCER	Apr 28, 1983	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K823262	MODEL SP5800 #8 FRENCH INTRO. KIT	Jan 18, 1983	Substantially Equivalent	GOULD, INC.
K822834	ACCESS PERCUTANEOUS INTRODUCER SET	Nov 01, 1982	Substantially Equivalent	ACCESS DEVICES, INC.
K822593	PERCUTANEOUS CATHETER INTRODUCER SET	Sep 28, 1982	Substantially Equivalent	VERTEX MEDICAL CORP.
K822247	CATH-SEAL	Aug 19, 1982	Substantially Equivalent	UNIVERSAL MEDICAL INSTRUMENT CORP.
K821324	ARGYLE INTRAMEDICUT CATHETER KIT	Jul 14, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K821188	INTRODUCER SET	Jul 08, 1982	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K820834	PERCOR PERCUTANEOUS INTRODUCER	Apr 14, 1982	Substantially Equivalent	DATASCOPE CORP.
K820710	NEONATAL INTRODUCER KIT	Apr 01, 1982	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K820581	NORTON JUGULAR KITS	Mar 18, 1982	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K813143	DESILET	Nov 27, 1981	Substantially Equivalent	EXCO, INC.
K813019	PERCUTANEOUS INTRODUCER: SELDINGER STYLE	Nov 16, 1981	Substantially Equivalent	DIP, INC.
K812973	PERCUTANEOUS INTRODUCER COURNAND STYLE	Nov 16, 1981	Substantially Equivalent	DIP, INC.
K812964	INTRODUCER, PERCUTANEOUS SELDINGER	Nov 16, 1981	Substantially Equivalent	TRIAD MEDICAL DIVISION
K812502	IMPLANTAID LEAD INTRODUCER #319-10 & 12	Oct 13, 1981	Substantially Equivalent	INTERMEDICS, INC.
K812325	INTK-08 8 FRENCH INTRODUCER KIT W/SIDE	Sep 21, 1981	Substantially Equivalent	SORENSEN RESEARCH
K812143	INTRODUCER, PERCUTANEOUS	Aug 18, 1981	Substantially Equivalent	WILLSON
K800356	PERMANENT LEAD INTRADUCER	May 28, 1980	Substantially Equivalent	DAIG CORP.
K800621	PERCUTANEOUS CATHETER INTRODUCER ADAPTER	Apr 24, 1980	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K800620	VENOUS M/A INTERNAL JUGULAR KIT	Apr 24, 1980	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K800619	THERMODILUTION CATHETER INTRO. KIT	Apr 24, 1980	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K800580	PERCUTANEOUS CATHETER INTRODUCER	Apr 02, 1980	Substantially Equivalent	ALVA MEDICAL, INC.
K792172	PERCUTANEOUS SHEATH INTRO. KIT OR TRAY	Nov 13, 1979	Substantially Equivalent	STANCO MEDICAL, INC.
K792171	COMPLETE TRAY CENTRAL VENOUS PRESSURE	Nov 13, 1979	Substantially Equivalent	STANCO MEDICAL, INC.
K792170	PERCUTANEOUS SHEATH (MULTI-CATH)SIDE	Nov 13, 1979	Substantially Equivalent	STANCO MEDICAL, INC.
K792131	TEMPORARY TRANSVENOUS PACMKER. ELECTRODE	Nov 13, 1979	Substantially Equivalent	STANCO MEDICAL, INC.
K792130	TRANSVENOUS BALLOON CATH. INTRO. KIT	Nov 13, 1979	Substantially Equivalent	STANCO MEDICAL, INC.
K791963	USCI MULLINS TRANSSEPTAL CATHETER INTRO.	Nov 13, 1979	Substantially Equivalent	C.R. BARD, INC.
K791129	PERMANENT LEAD INTRADUCER	Jul 17, 1979	Substantially Equivalent	DAIG CORP.
K790034	INTRODUCERS	Feb 01, 1979	Substantially Equivalent	CLINCAL INSTRUMENTS CORP.
K781954	CATHETER INTRODUCERS, ARTERISE	Nov 29, 1978	Substantially Equivalent	C.R. BARD, INC.
K780532	PERCUTANEOUS SHEATH INTRODUCER KIT	Apr 21, 1978	Substantially Equivalent	ARROW INTL., INC.
K771982	888 ARTERIAL/VENOUS CATHETER INTRODUCER	Nov 02, 1977	Substantially Equivalent	USCI, DIV. C.R. BARD, INC.
K771042	INTRODUCER, CAT. #INT-05FR.	Jul 13, 1977	Substantially Equivalent	SORENSEN RESEARCH
K771041	INTRODUCER, CAT. #INT-06FR.	Jul 13, 1977	Substantially Equivalent	SORENSEN RESEARCH
K771040	INTRODUCER, CAT. #INT-07FR.	Jun 29, 1977	Substantially Equivalent	SORENSEN RESEARCH
K770561	CATHETER,PERCUTANEOUS INTRODUC. & SHEATH	Apr 26, 1977	Substantially Equivalent	USCI, DIV. C.R. BARD, INC.
K770427	CATHETER INTRODUCER KIT	Mar 16, 1977	Substantially Equivalent	ELECTRO-CATHETER CORP.

FEI Numbers

This FDA classification entry is associated with 268 FEI numbers. Click on an entry to view related FDA registrations.

1000112877: 433 registrations

1000112968: 424 registrations

1000117748: 143 registrations

1000120555: 57 registrations

1000121056: 328 registrations

1000121130: 25 registrations

1000123180: 115 registrations

1000132370: 44 registrations

1000136269: 265 registrations

1000138054: 760 registrations

1000222374: 10 registrations

1000306139: 80 registrations

1000306216: 55 registrations

1000393132: 174 registrations

1000512168: 447 registrations

1000514656: 190 registrations

1000518731: 132 registrations

1000519796: 20 registrations

1000523114: 64 registrations

1000563940: 52 registrations

1016427: 97 registrations

1018233: 409 registrations

1018470: 468 registrations

1035166: 41 registrations

1043214: 577 registrations

1048735: 291 registrations

1118880: 21 registrations

1220452: 34 registrations

1220477: 911 registrations

1220648: 9 registrations

1221019: 2 registrations

1282497: 47 registrations

1318694: 28 registrations

1319211: 63 registrations

1417485: 72 registrations

1450662: 954 registrations

1526711: 131 registrations

1526863: 66 registrations

1625425: 139 registrations

1625685: 37 registrations

1643817: 565 registrations

1710034: 25 registrations

1713910: 76 registrations

1721504: 249 registrations

1721676: 747 registrations

1721686: 241 registrations

1820334: 521 registrations

1824619: 64 registrations

1828424: 15 registrations

1921846: 275 registrations

1928237: 782 registrations

2011171: 834 registrations

2015691: 181 registrations

2017865: 66 registrations

2020394: 141 registrations

2024168: 107 registrations

2024311: 106 registrations

2124215: 406 registrations

2182208: 127 registrations

2182269: 74 registrations

2183744: 663 registrations

2183787: 20 registrations

2183870: 87 registrations

2245270: 49 registrations

2246552: 325 registrations

2518902: 138 registrations

2521402: 104 registrations

2523676: 144 registrations

2527072: 16 registrations

2528981: 215 registrations

2648045: 124 registrations

2828: 68 registrations

2938836: 20 registrations

3000203000: 349 registrations

3000204727: 21 registrations

3000206435: 390 registrations

3000215205: 174 registrations

3000268902: 58 registrations

3000718472: 22 registrations

3001124136: 59 registrations

3001236905: 677 registrations

3001237677: 14 registrations

3001374820: 5 registrations

3001451463: 84 registrations

3001451473: 2 registrations

3001452571: 20 registrations

3002095335: 124 registrations

3002468371: 157 registrations

3002558692: 135 registrations

3002601200: 3 registrations

3002615969: 56 registrations

3002648230: 7 registrations

3002806434: 45 registrations

3002806469: 63 registrations

3002806476: 19 registrations

3002806565: 277 registrations

3002806575: 91 registrations

3002807111: 309 registrations

3002807314: 432 registrations

3002807439: 44 registrations

3002807548: 9 registrations

3002807847: 54 registrations

3002808050: 21 registrations

3002808327: 59 registrations

3002808464: 16 registrations

3002808467: 14 registrations

3002827704: 66 registrations

3002879021: 31 registrations

3002894438: 5 registrations

3002902735: 417 registrations

3003015552: 444 registrations

3003040625: 290 registrations

3003076831: 367 registrations

3003094851: 292 registrations

3003248396: 56 registrations

3003289723: 8 registrations

3003528016: 52 registrations

3003565456: 67 registrations

3003610571: 6 registrations

3003637635: 10 registrations

3003737899: 262 registrations

3003767881: 72 registrations

3003769549: 7 registrations

3003898360: 136 registrations

3003915875: 145 registrations

3004091615: 114 registrations

3004111573: 356 registrations

3004134316: 17 registrations

3004193842: 5 registrations

3004563801: 16 registrations

3004635528: 79 registrations

3004784537: 57 registrations

3004785273: 34 registrations

3004970277: 14 registrations

3005011024: 409 registrations

3005168196: 82 registrations

3005232773: 11 registrations

3005334138: 201 registrations

3005580113: 111 registrations

3005747797: 800 registrations

3005846326: 140 registrations

3005994106: 12 registrations

3006082230: 372 registrations

3006131984: 19 registrations

3006260740: 216 registrations

3006425876: 120 registrations

3006950086: 268 registrations

3007207906: 22 registrations

3007284313: 13 registrations

3007603855: 3 registrations

3007697249: 15 registrations

3007830707: 9 registrations

3007836437: 41 registrations

3007882731: 15 registrations

3008002401: 8 registrations

3008002452: 202 registrations

3008114965: 383 registrations

3008261722: 7 registrations

3008307705: 125 registrations

3008328690: 3 registrations

3008361782: 5 registrations

3008397795: 46 registrations

3008403546: 40 registrations

3008452825: 30 registrations

3008514120: 12 registrations

3008824097: 46 registrations

3008853977: 64 registrations

3008906816: 16 registrations

3008998256: 35 registrations

3009211636: 67 registrations

3009291251: 68 registrations

3009350690: 73 registrations

3009393076: 4 registrations

3009420598: 61 registrations

3009437315: 8 registrations

3009605245: 18 registrations

3009746061: 97 registrations

3009888344: 311 registrations

3009905888: 16 registrations

3009970887: 3 registrations

3010041511: 587 registrations

3010055973: 92 registrations

3010131137: 206 registrations

3010141307: 6 registrations

3010155661: 185 registrations

3010200163: 4 registrations

3010220595: 187 registrations

3010273872: 290 registrations

3010291427: 90 registrations

3010421104: 31 registrations

3010425778: 116 registrations

3010432890: 119 registrations

3010532612: 32 registrations

3010665433: 29 registrations

3010882708: 11 registrations

3010966701: 23 registrations

3011024991: 72 registrations

3011063223: 2 registrations

3011237770: 70 registrations

3011396687: 9 registrations

3011493920: 5 registrations

3011564431: 8 registrations

3011610434: 43 registrations

3011623145: 8 registrations

3011642792: 83 registrations

3011657089: 4 registrations

3011689956: 141 registrations

3011752740: 2 registrations

3012050423: 50 registrations

3012159165: 25 registrations

3012179728: 109 registrations

3012307300: 358 registrations

3012536737: 270 registrations

3013162291: 45 registrations

3013288201: 31 registrations

3013300026: 75 registrations

3013400708: 7 registrations

3013557562: 654 registrations

3013666336: 13 registrations

3013758550: 82 registrations

3013764800: 172 registrations

3013986346: 8 registrations

3014272734: 22 registrations

3014312726: 56 registrations

3014687026: 13 registrations

3015138222: 3 registrations

3015173212: 285 registrations

3015309643: 267 registrations

3015453963: 66 registrations

3015615738: 82 registrations

3015859709: 148 registrations

3015970743: 12 registrations

3016591327: 84 registrations

3016678045: 154 registrations

3016904853: 78 registrations

3016986313: 1 registration

3017060084: 67 registrations

3017298588: 5 registrations

3017406698: 26 registrations

3017636737: 186 registrations

3019751610: 25 registrations

3019807891: 101 registrations

3020283264: 23 registrations

3020347218: 28 registrations

3020954746: 8 registrations

3021558379: 1 registration

3021951050: 2 registrations

3022815697: 6 registrations

3023287212: 42 registrations

3025028711: 2 registrations

3025341484: 7 registrations

3027097031: 1 registration

3027329034: 3 registrations

3027366703: 1 registration

3030236028: 9 registrations

3030390308: 7 registrations

3030446844: 160 registrations

3030447506: 78 registrations

3030574705: 46 registrations

3031983053: 3 registrations

3032916632: 114 registrations

3033589330: 268 registrations

3034205957: 7 registrations

3036802499: 3 registrations

3036802567: 1 registration

3037050339: 3 registrations

3038188187: 1 registration

3038191255: 1 registration