Product Code: LIT FDA class 2 21 CFR 870.1250

Catheter, Angioplasty, Peripheral, Transluminal

Cardiovascular

A peripheral transluminal angioplasty catheter is an intravascular device inserted via a peripheral artery and advanced to the site of a stenosis or occlusion, where an inflatable balloon at the catheter tip is expanded to dilate the narrowed vessel and restore adequate blood flow in patients with peripheral arterial disease. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIT and is regulated under 21 CFR 870.1250 within the Cardiovascular specialty. This device is eligible for third-party review.

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510(k)s

403

FEI Numbers

Registration Numbers

Unique Applicants

118

Years Active

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Basic Information

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

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 403 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260304	WAVE PTA Balloon Catheter	May 20, 2026	Substantially Equivalent	WAVE Medical AG
K252512	Armada 14 NC PTA Catheter	Feb 13, 2026	Substantially Equivalent	ABBOTT MEDICAL
K251915	Amethyst HP PTA OTW 0.035 Catheter	Dec 18, 2025	Substantially Equivalent	Natec Medical , Ltd.
K250706	Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	Apr 04, 2025	Substantially Equivalent	Biotronik, Inc.
K243704	Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter	Feb 27, 2025	Substantially Equivalent	Brosmed Medical Co., Ltd.
K241040	Amethyst HP PTA OTW 0.035 Catheter	Dec 18, 2024	Substantially Equivalent	Natec Medical , Ltd.
K242419	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	Nov 15, 2024	Substantially Equivalent	Creagh Medical Ltd. Dba Surmodics, Inc.
K241740	Finesse Injectable PTA Balloon Dilatation Catheter	Jul 16, 2024	Substantially Equivalent	Summa Therapeutics
K241711	Oscar Peripheral Multifunctional Catheter system	Jul 11, 2024	Substantially Equivalent	Biotronik, Inc.
K241683	Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314	Jul 10, 2024	Substantially Equivalent	Boston Scientific Corporation
K241025	JADE PLUS PTA Balloon Dilatation Catheter	Jun 11, 2024	Substantially Equivalent	OrbusNeich Medical (Shenzhen) Co., Ltd.
K231402	HP PTA Balloon Dilatation Catheter	Dec 20, 2023	Substantially Equivalent	Kossel Medtech (Suzhou) Co., Ltd.
K230263	Finesse Injectable PTA Balloon Dilatation Catheter	May 26, 2023	Substantially Equivalent	Summa Therapeutics, LLC
K214009	D·Kaptain PTA High Pressure Balloon Dilatation Catheter	Apr 05, 2023	Substantially Equivalent	Dk Medical Technology Co., Ltd.
K230191	Arise UHP Dilatation Catheter	Mar 22, 2023	Substantially Equivalent	Creagh Medical, Ltd.
K222065	Passeo-35 Xeo Peripheral Dilatation Catheter	Feb 16, 2023	Substantially Equivalent	Biotronik, Inc.
K223177	Highlander 014 PTA Balloon Dilatation Catheter	Jan 20, 2023	Substantially Equivalent	C.R. Bard, Inc.
K221245	PTA Balloon Dilatation Catheter	Dec 14, 2022	Substantially Equivalent	Kossel Medtech (Suzhou) Co., Ltd.
K221414	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	Sep 02, 2022	Substantially Equivalent	Silk Road Medical, Inc.
K221832	SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter	Aug 22, 2022	Substantially Equivalent	Cordis US Corp
K212215	Tiche PTA Balloon Dilatation Catheter	Jul 19, 2022	Substantially Equivalent	Brosmed Medical Co., Ltd.
K214038	Oscar Peripheral Multifunctional Catheter system	Jul 06, 2022	Substantially Equivalent	Biotronik, Inc.
K220410	Ebony HP PTA OTW 0.035 Catheter	Jun 29, 2022	Substantially Equivalent	Natec Medical , Ltd.
K221339	Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection	Jun 09, 2022	Substantially Equivalent	Contego Medical, Inc.
K221057	Viatrac 14 Plus Peripheral Dilatation Catheter	May 05, 2022	Substantially Equivalent	Abbott Vascular
K213631	Chocolate PTA Balloon Catheter	Dec 15, 2021	Substantially Equivalent	Medtronic, Inc.
K201246	PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)	Aug 03, 2021	Substantially Equivalent	Qualimed USA, LLC
K211044	Sublime Radial Access 018 RX Dilatation Catheter	Jun 16, 2021	Substantially Equivalent	Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,
K210626	SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter	Apr 23, 2021	Substantially Equivalent	Cordis Corporation
K202231	JADE	Dec 10, 2020	Substantially Equivalent	OrbusNeich Medical (Shenzhen) Co., Ltd.
K202800	Pacific Plus PTA Catheter	Nov 18, 2020	Substantially Equivalent	Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)
K201377	SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter	Oct 09, 2020	Substantially Equivalent	Cordis Corporation
K201170	Athletis PTA Balloon Dilatation Catheter	Sep 15, 2020	Substantially Equivalent	Boston Scientific Corporation
K201333	SABER .035 PTA Dilatation Catheter	Sep 11, 2020	Substantially Equivalent	Cordis Corporation
K201794	Jade	Jul 28, 2020	Substantially Equivalent	OrbusNeich Medical (Shenzhen) Co., Ltd.
K192399	Infinity Angioplasty Balloon Catheter	May 20, 2020	Substantially Equivalent	Infinity Angioplasty Balloon Company, LLC
K200700	Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter	May 14, 2020	Substantially Equivalent	Creagh Medical, Ltd.
K191275	AllInCath 035M PTA Balloon Dilatation Catheter	Jan 15, 2020	Substantially Equivalent	Nexstep Medical
K192907	Advocate PTA Catheter	Nov 26, 2019	Substantially Equivalent	Merit Medical Systems, Inc.
K190037	Cronus HP PTA Balloon Catheter	Oct 24, 2019	Substantially Equivalent	Nipro Medical Corporation
K192318	Ultraverse 014 and 018 PTA Balloon Dilatation Catheters	Oct 03, 2019	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K190753	EverCrossTM 0.035 OTW PTA Dilatation Catheter	Apr 23, 2019	Substantially Equivalent	Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
K181529	Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection	Dec 06, 2018	Substantially Equivalent	Contego Medical, LLC
K181128	Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)	Sep 06, 2018	Substantially Equivalent	Contego Medical, LLC
K181323	Atlas Gold PTA Dilatation Catheter	Aug 03, 2018	Substantially Equivalent	C.R. Bard, Inc.
K180007	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	Apr 19, 2018	Substantially Equivalent	Creagh Medical, Ltd.
K173515	Admiral Xtreme	Apr 12, 2018	Substantially Equivalent	Medtronic Vascular
K173894	Jade PTA Balloon Dilatation Catheter	Feb 09, 2018	Substantially Equivalent	Orbusneich Medical Trading, Inc.
K172494	PROTEUS PTA Balloon Catheter with Embolic Capture Feature	Dec 15, 2017	Substantially Equivalent	Angioslide, Ltd.
K173621	Advocate PTA Catheter	Dec 13, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K171251	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	Sep 08, 2017	Substantially Equivalent	Creagh Medical
K172033	Pirouette High Pressure (HP)	Aug 31, 2017	Substantially Equivalent	Arravasc, Ltd.
K171290	Vela RX PTA Balloon Dilatation Catheter	Jul 19, 2017	Substantially Equivalent	Curatia Medical
K170635	Chameleon PTA Balloon Catheter	Mar 30, 2017	Substantially Equivalent	Av Medical Technologies, Ltd.
K170193	Advance 14LP Low Profile PTA Balloon Dilatation Catheter	Feb 13, 2017	Substantially Equivalent	Cook Incorporated
K163231	Chameleon PTA Balloon Catheter	Jan 17, 2017	Substantially Equivalent	Av Medical Technologies, Ltd.
K163479	R2P Metacross RX	Jan 11, 2017	Substantially Equivalent	KANEKA Corporation
K160941	Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter	Dec 13, 2016	Substantially Equivalent	Brosmed Medical Co., Ltd.
K162316	Pirouette 014	Nov 22, 2016	Substantially Equivalent	Arravasc, Ltd.
K162350	Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018	Nov 04, 2016	Substantially Equivalent	Boston Scientific Corporation
K161427	Pirouette 035	Jul 30, 2016	Substantially Equivalent	Arravasc Limited
K160256	Polux , Minerva and Atropos PTA Balloon Dilatation Catheter	Jul 29, 2016	Substantially Equivalent	Brosmed Medical Co., Ltd.
K160013	Crosperio OTW	Apr 29, 2016	Substantially Equivalent	KANEKA Corporation
K160004	Crosstella OTW	Apr 29, 2016	Substantially Equivalent	KANEKA Corporation
K152934	MMS PTA Balloon Catheter	Apr 25, 2016	Substantially Equivalent	Micro Medical Solutions, Inc.
K152887	Crosperio RX PTA Balloon Dilatation Catheter	Jan 22, 2016	Substantially Equivalent	KANEKA Corporation
K152873	Crosstella RX Balloon Dilatation Catheter	Jan 22, 2016	Substantially Equivalent	KANEKA Corporation
K151141	Cronus HP - High Pressure Peripheral Balloon Catheter	Jan 14, 2016	Substantially Equivalent	Nipro Medical Corporation
K152665	PolarCath Peripheral Dilatation System	Oct 26, 2015	Substantially Equivalent	Nucyro Vascular, LLC
K152240	Passeo-14 Peripheral Dilatation Catheter	Oct 08, 2015	Substantially Equivalent	Biotronik, Inc.
K151744	Passeo-18 Peripheral Dilation Catheter	Oct 08, 2015	Substantially Equivalent	Biotronik, Inc.
K152080	Metacross OTW PTA Balloon Dilatation Catheter	Sep 24, 2015	Substantially Equivalent	KANEKA Corporation
K151678	Chameleon PTA Balloon Catheter	Sep 21, 2015	Substantially Equivalent	Av Medical Technologies, Ltd.
K152230	Ebony PTA .014 RX Pheripheral Dilatation Catheter	Sep 03, 2015	Substantially Equivalent	Natec Medical
K151153	Pirouette 018	Aug 20, 2015	Substantially Equivalent	Arravasc Limited
K150452	ComboCath OTW PTA Dilatation Catheter	Aug 13, 2015	Substantially Equivalent	Summa Therapeutics, LLC
K143193	Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters	Jul 24, 2015	Substantially Equivalent	Boston Scientific
K151317	Armada 18 PTA Catheter	Jul 06, 2015	Substantially Equivalent	Abbott Vascular
K143093	0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)	Jun 24, 2015	Substantially Equivalent	Hotspur Technologies, Inc.,
K150303	XXL Vascular Balloon Dilatation Catheter	Jun 15, 2015	Substantially Equivalent	Boston Scientific Corp
K143041	Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter	Jun 04, 2015	Substantially Equivalent	Natec Medical , Ltd.
K142954	PTA 14 Balloon Dilatation Catheter OTW	May 28, 2015	Substantially Equivalent	Texasmedical Technologies, Inc.
K143561	ELM PTA Balloon Dilatation Catheter	May 19, 2015	Substantially Equivalent	O'Connell Regulatory Consultants, Inc.
K150946	FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm	May 08, 2015	Substantially Equivalent	Ostial Corporation
K143036	Ebony PTA 0.035 Peripheral Dilatation Catheter	Mar 30, 2015	Substantially Equivalent	Natec Medical , Ltd.
K143652	Vector PTA Balloon Dilatation Catheter	Feb 26, 2015	Substantially Equivalent	Vector Corporation, LLC
K142459	Ebony PTA 0.014 RX Peripheral Dilatation Catheter	Feb 03, 2015	Substantially Equivalent	Natec Medical , Ltd.
K142379	Passeo-35 PTA Catheter	Dec 05, 2014	Substantially Equivalent	Biotronik, Inc.
K142654	Fortrex 0.035 OTW PTA Balloon Catheter	Oct 28, 2014	Substantially Equivalent	Covidien, LLC
K141150	PTA BALLOON DILATATION CATHETER	Sep 25, 2014	Substantially Equivalent	Boston Scientific Corp
K142261	Ultraverse 035 PTA Balloon Dilatation Catheter	Sep 24, 2014	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K142300	Arrow GPSCath Balloon Dialation Catheter (150 cm)	Sep 17, 2014	Substantially Equivalent	Hotspur Technologies, Inc.,
K141521	MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER	Aug 21, 2014	Substantially Equivalent	Boston Scientific Corporation
K141118	NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER	Jul 18, 2014	Substantially Equivalent	Ev3, Inc.
K141112	STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER	Jul 16, 2014	Substantially Equivalent	Boston Scientific
K140351	ARROW GPSCATH BALLOON DILATATION CATHETER	Jul 02, 2014	Substantially Equivalent	Hotspur Technologies,Inc Subsidiary of Teleflex ME
K133861	FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM	Jul 02, 2014	Substantially Equivalent	Ostial Corporation
K133843	SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER	Jun 27, 2014	Substantially Equivalent	Cordis Corporation
K132810	GLADIATOR ELITE PTA BALLOON DILATATION CATHETER	Feb 28, 2014	Substantially Equivalent	Boston Scientific Corp
K133043	PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE	Dec 06, 2013	Substantially Equivalent	Angioslide, Ltd.
K132020	ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER	Oct 25, 2013	Substantially Equivalent	Cook, Inc.
K132430	STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER	Oct 17, 2013	Substantially Equivalent	Boston Scientific Corp
K132777	NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER	Sep 26, 2013	Substantially Equivalent	Ev3, Inc.
K130397	ARROW GPSCATH BALLOON DILATATION CATHETER	Jun 20, 2013	Substantially Equivalent	Hotspur Technologies
K130414	CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018	Jun 15, 2013	Substantially Equivalent	Trireme Medical, Inc.
K131329	VECTOR PTA BALLOON DILATATION CATHETER	Jun 06, 2013	Substantially Equivalent	R4 Vascular, Inc.
K130293	ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER	May 31, 2013	Substantially Equivalent	Cook, Inc.
K131199	ULTRAVERSE RX PTA BALLOON DILATATION CATHETER	May 30, 2013	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K130911	RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER	May 24, 2013	Substantially Equivalent	Ev3, Inc.
K130786	SLEEK OTW PTA CATHETER	May 03, 2013	Substantially Equivalent	C.R. Bard, Inc.
K130161	PASSEO-35	Apr 23, 2013	Substantially Equivalent	Biotronik, Inc.
K123544	RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER	Feb 12, 2013	Substantially Equivalent	Ev3, Inc.
K123358	PACIFIC PLUS	Jan 29, 2013	Substantially Equivalent	Medtronic Vascular
K122984	ATLAS GOLD PTA DILATATION CATHETER	Oct 22, 2012	Substantially Equivalent	C.R. Bard, Inc.
K122379	FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM	Sep 05, 2012	Substantially Equivalent	Ostial Corporation
K122070	CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G	Aug 15, 2012	Substantially Equivalent	Trireme Medical, Inc.
K121856	ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION	Jul 11, 2012	Substantially Equivalent	C.R. Bard, Inc.
K121175	FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM	Jun 29, 2012	Substantially Equivalent	Ostial Corporation
K121442	POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER	Jun 14, 2012	Substantially Equivalent	Cordis Corporation
K121385	VECTOR	Jun 14, 2012	Substantially Equivalent	R4 Vascular, Inc.
K121402	CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G	Jun 08, 2012	Substantially Equivalent	Trireme Medical, Inc.
K120164	PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE	Jun 08, 2012	Substantially Equivalent	Angioslide, Ltd.
K121265	AMPHIRION PLUS PTA CATHETER	May 22, 2012	Substantially Equivalent	Medtronic, Inc.
K112797	POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER	May 04, 2012	Substantially Equivalent	Cordis Corp.
K120971	ATLAS PTA BALLOON DILATATION CATHETER	Apr 19, 2012	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K120722	RIVAL PTA DILATATION CATHETER	Apr 19, 2012	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K120805	PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE	Apr 13, 2012	Substantially Equivalent	Angioslide, Ltd.
K120738	FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM	Mar 29, 2012	Substantially Equivalent	Ostial Corporation
K120677	CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)	Mar 15, 2012	Substantially Equivalent	Trireme Medical, Inc.
K120660	CONQUEST 40 PTA DILATATION CATHETER	Mar 15, 2012	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K113769	GPSCATH BALLON DILATATION CATHETER	Jan 20, 2012	Substantially Equivalent	Hotspur Technologies
K113681	GLADIATOR PTA BALLOON DILATION CATHETER	Jan 11, 2012	Substantially Equivalent	Boston Scientific
K113468	ELM PTA BALLON DILATATION CATHETER	Dec 20, 2011	Substantially Equivalent	Creagh Medical, Ltd.
K113300	ATB ADVANCE PTA DILATATION CATHETER	Dec 09, 2011	Substantially Equivalent	Cook, Inc.
K112513	EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER	Dec 09, 2011	Substantially Equivalent	Natec Medical , Ltd.
K112697	CHARGER PTA BALLON DILATATION CATHETER	Nov 30, 2011	Substantially Equivalent	Boston Scientific
K111899	ARMADA 35/35LL PTA CATHETER	Oct 03, 2011	Substantially Equivalent	Abbott Vascular
K111295	.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS	May 31, 2011	Substantially Equivalent	Boston Scientific Corporation
K110319	EVERCROSS 0.035 OTW PTA DILATATION CATHETER	Apr 14, 2011	Substantially Equivalent	Ev3, Inc.
K103751	MUSTANG BALLOON DILATATION CATHETERS	Mar 22, 2011	Substantially Equivalent	Boston Scientific
K102482	FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM	Feb 25, 2011	Substantially Equivalent	Ostial Corporation
K103354	EBONY PTA .035 PERIPHERAL DILATATION CATHETER	Feb 23, 2011	Substantially Equivalent	Natec Medical , Ltd.
K103464	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	Dec 22, 2010	Substantially Equivalent	Medtronic, Inc.
K102645	WILLOW/ELM PTA BALLOON DILATATION CATHETER	Dec 10, 2010	Substantially Equivalent	Creagh Medical, Ltd.
K102705	ARMADA 14 PTA CATHETER	Dec 07, 2010	Substantially Equivalent	Abbott Vascular, Inc.
K103322	EVERCROSS 0.035 OTW PTA DILATION CATHETER	Dec 06, 2010	Substantially Equivalent	Ev3, Inc.
K102035	SLEEK OTW PTA CATHETERS	Dec 01, 2010	Substantially Equivalent	ClearStream Technologies , Ltd.
K101361	REEFLEX PTA CATHETER	Aug 04, 2010	Substantially Equivalent	ClearStream Technologies , Ltd.
K101047	PTA-DUO PTA BALLOON CATHETER	Jul 13, 2010	Substantially Equivalent	Hotspur Technologies
K101062	GLIDER PTA BALLOON CATHETER	May 12, 2010	Substantially Equivalent	Trireme Medical, Inc.
K100921	ADMIRAL XTREME PTA BALLOON DILATATION CATHETER	Apr 30, 2010	Substantially Equivalent	Invatec S.P.A.
K090364	EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE	Mar 23, 2010	Substantially Equivalent	Angioslide, Ltd.
K093965	ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS	Mar 17, 2010	Substantially Equivalent	C.R. Bard, Inc.
K100490	LITEPAC, MODEL 682	Mar 16, 2010	Substantially Equivalent	ClearStream Technologies , Ltd.
K093970	PICA CATHETER	Jan 15, 2010	Substantially Equivalent	Penumbra, Inc.
K093139	BANTAM,48XXXXXX, 50XXXXXX	Dec 30, 2009	Substantially Equivalent	ClearStream Technologies , Ltd.
K093720	STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO	Dec 23, 2009	Substantially Equivalent	Boston Scientific Corp
K093636	STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX	Dec 23, 2009	Substantially Equivalent	Boston Scientific Corp
K093286	POWERCROSS .018 OTW PTA DILATION CATHETER	Nov 13, 2009	Substantially Equivalent	Ev3, Inc.
K092361	REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER	Oct 29, 2009	Substantially Equivalent	Invatec S.P.A.
K092455	MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM	Sep 04, 2009	Substantially Equivalent	Boston Scientific Corporation
K092286	FOX SV PTA CATHETER	Aug 27, 2009	Substantially Equivalent	Abbott Vascular
K080982	STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS	Jul 14, 2008	Substantially Equivalent	Boston Scientific Corp
K081417	FOXCROSS PTA CATHETER	Jun 04, 2008	Substantially Equivalent	Abbott Vascular, Inc.
K080925	FOX PLUS PTA CATHETER	Apr 28, 2008	Substantially Equivalent	Abbott Vascular, Inc.
K080264	MODIFICATION TO: FOX PLUS PTA CATHETER	Mar 26, 2008	Substantially Equivalent	Abbott Vascular-Vascular Solutions
K072947	SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS	Feb 08, 2008	Substantially Equivalent	ClearStream Technologies , Ltd.
K072798	VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER	Jan 31, 2008	Substantially Equivalent	Abbott Vascular-Vascular Solutions
K073318	BIPORE BALLOON DILATION CATHETER	Jan 16, 2008	Substantially Equivalent	Bipore, Inc.
K073472	VACCESS PTA BALLOON DILATATION CATHETER	Jan 09, 2008	Substantially Equivalent	C.R. Bard, Inc.
K072765	PASSEO 18	Dec 12, 2007	Substantially Equivalent	Biotronik, Inc.
K072824	FOX SV PTA CATHETER	Oct 23, 2007	Substantially Equivalent	Abbott Laboratories
K071309	BLUE MAX BALLOON DILATATION CATHETER	Jul 13, 2007	Substantially Equivalent	Boston Scientific Corp
K071042	POLARCATH PERIPHERAL DILATATION SYSTEM	Jun 13, 2007	Substantially Equivalent	Boston Scientific Corp
K071189	CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER	May 16, 2007	Substantially Equivalent	Cordis Europa, N.V.
K063563	CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER	Mar 07, 2007	Substantially Equivalent	Cordis Europa, N.V.
K062843	FOX SV PTA CATHETER	Oct 17, 2006	Substantially Equivalent	Abbott Laboratories
K060960	BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER	Apr 12, 2006	Substantially Equivalent	Boston Scientific Corporation
K060959	SYMMETRY BALLOON DILATATION CATHETER	Apr 12, 2006	Substantially Equivalent	Boston Scientific Corporation
K052757	PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER	Oct 28, 2005	Substantially Equivalent	Biotronik AG
K052038	PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM	Aug 16, 2005	Substantially Equivalent	Boston Scientific Corporation
K051916	POLAR CATH PERIPHERAL DILATATION SYSTEM	Aug 05, 2005	Substantially Equivalent	Cryo Vascular Systems, Inc.
K051042	METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000	Aug 05, 2005	Substantially Equivalent	Angiometrx, Inc.
K051519	FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)	Jun 21, 2005	Substantially Equivalent	Abbott Laboratories (Perclose, Inc.)
K050645	CORDIS AMIIA .014 PTA BALLOON CATHETER	Apr 01, 2005	Substantially Equivalent	Cordis Corp.
K041293	BIOPORE BALLOON DILATION CATHETER	Jul 09, 2004	Substantially Equivalent	Bipore, Inc.
K040954	FOX PLUS PTA CATHETER	May 11, 2004	Substantially Equivalent	Abbott Laboratories, Inc.
K030742	POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM	Aug 29, 2003	Substantially Equivalent	Cryo Vascular Systems, Inc.
K030062	ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0	Apr 03, 2003	Substantially Equivalent	Avantec Vascular Corp.
K023504	MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER	Nov 13, 2002	Substantially Equivalent	Cook, Inc.
K021996	BOLTON PTA CATHETER	Aug 23, 2002	Substantially Equivalent	Bolton Medical, Inc.
K020854	MODIFICATION TO FOX PTA CATHETER	Apr 11, 2002	Substantially Equivalent	Jomed AG
K003972	NUMED GHOST II PTA CATHETERS	Jan 11, 2001	Substantially Equivalent	NuMED, Inc.
K003276	TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107	Dec 01, 2000	Substantially Equivalent	NuMED, Inc.
K003114	NUMED TYSHAK AND Z-MED PTV CATHETERS	Nov 01, 2000	Substantially Equivalent	NuMED, Inc.
K003052	NUMED TYSHAK II AND Z-MED II PTV CATHETERS	Nov 01, 2000	Substantially Equivalent	NuMED, Inc.
K003159	CORDIS SLALOM PTA BALLOON CATHETER	Oct 30, 2000	Substantially Equivalent	Cordis Corp.
K991977	TYSHAK, MODEL 102 AND Z-MED, MODEL 302	Sep 27, 2000	Substantially Equivalent	NuMED, Inc.
K001134	GAZELLE BALLOON DILATATION CATHETER	Aug 31, 2000	Substantially Equivalent	Boston Scientific Corp
K993913	TRUE	Aug 09, 2000	Substantially Equivalent	Infinity Extrusion & Engineering, Inc.
K001087	PTA BALLOON CATHETER	Jul 20, 2000	Substantially Equivalent	Cook, Inc.
K000798	TALON BALLOON DILATION CATHETER	Jun 08, 2000	Substantially Equivalent	Boston Scientific Corp
K992320	MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER	May 18, 2000	Substantially Equivalent	Boston Scientific Corp
K000570	BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA	Apr 13, 2000	Substantially Equivalent	Boston Scientific Corp
K993305	TRANSLUMINAL BALLOON DILATATION CATHETER	Apr 10, 2000	Substantially Equivalent	Boston Scientific Corp
K000101	RX VIATRAC 14 PERIPHERAL DILATATION CATHETER	Feb 10, 2000	Substantially Equivalent	Guidant Corp.
K993639	RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER	Jan 27, 2000	Substantially Equivalent	Guidant Corp.
K991540	WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER	Sep 29, 1999	Substantially Equivalent	AngioDynamics, Inc.
K992825	CORDIS EXTREME PTA BALLOON CATHETER	Sep 15, 1999	Substantially Equivalent	Cordis Corp.
K991811	CORDIS MAXI DS PTA BALLOON CATHETER	Jun 15, 1999	Substantially Equivalent	Cordis Corp.
K983830	COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER	Apr 16, 1999	Substantially Equivalent	Mallinckroot, Inc.
K983650	BIPORE BALLOON DILATATION CATHETER	Feb 17, 1999	Substantially Equivalent	Bipore, Inc.
K983055	RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003	Dec 30, 1998	Substantially Equivalent	Guidant Corp.
K980390	PTA BALLOON CATHETER	Aug 20, 1998	Substantially Equivalent	Cook, Inc.
K981906	MODIFICATION FOR PTA BALLOON CATHETER	Jun 29, 1998	Substantially Equivalent	Cook, Inc.
K973013	OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER	Jun 19, 1998	Substantially Equivalent	Vas-Cath, Inc.
K981407	OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER	May 20, 1998	Substantially Equivalent	Cordis Corp.
K972800	PTA BALLOON CATHETER	Apr 16, 1998	Substantially Equivalent	Cook, Inc.
K973563	BIPORE BALLOON DILATATION CATHETER	Apr 01, 1998	Substantially Equivalent	Bipore, Inc.
K972512	SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL	Feb 12, 1998	Substantially Equivalent	Boston Scientific Scimed, Inc.
K972744	COURIER ST BALLOON DILATATION CATHETER	Dec 11, 1997	Substantially Equivalent	Boston Scientific Corp
K972357	BLUE MAX - 20 BALLOON DILATATION CATHETER	Nov 19, 1997	Substantially Equivalent	Boston Scientific Corp
K971516	CORDIS POWERFLEX PLUS PTA BALLOON CATHETER	Jul 23, 1997	Substantially Equivalent	Cordis Corp.
K971579	CORDIS OPTA 5 PTA BALLOON CATHETER	Jul 18, 1997	Substantially Equivalent	Cordis Corp.
K971448	CORDIS OPTA LP PTA BALLOON CATHETER	Jul 03, 1997	Substantially Equivalent	Cordis Corp.
K971577	FOCUS-PV BALLOON DILATATION CATHETER	Jun 18, 1997	Substantially Equivalent	Cardiovascular Dynamics, Inc.
K971010	PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS	Jun 18, 1997	Substantially Equivalent	Cordis Corp.
K964881	ULTRAVERSE PTA CATHETER	May 28, 1997	Substantially Equivalent	Vas-Cath, Inc.
K970466	RADIUS PTCA GUIDEWIRE	May 20, 1997	Substantially Equivalent	Radius Medical Technologies, Inc.
K953647	MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING	May 16, 1997	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K970725	OPTI-PLAST XL 5.5 F PTA CATHETER	May 09, 1997	Substantially Equivalent	Vas-Cath, Inc.
K970620	CORDIS OPTA5 PTA BALLOON CATHETER	May 06, 1997	Substantially Equivalent	Cordis Corp.
K970379	CHANNEL BALLOON CATHETER	May 01, 1997	Substantially Equivalent	Boston Scientific Corp
K970299	JUPITER PTA CATHETERS (VARIOUS)	Apr 24, 1997	Substantially Equivalent	Cordis Corp.
K965183	VANTAGE PERIPHERAL DILATATION CATHETER	Apr 24, 1997	Substantially Equivalent	Guidant Corp.
K963688	FOCUS PV BALLOON DILATATION CATHETER	Mar 28, 1997	Substantially Equivalent	Cardiovascular Dynamics, Inc.
K963000	MAXI LD PTA BALLOON CATHETER	Feb 20, 1997	Substantially Equivalent	Cordis Corp.
K962945	CORDIS OPTA PTA BALLOON CATHETER	Oct 23, 1996	Substantially Equivalent	Cordis Corp.
K961980	BIPORE BALLOON DILATATION CATHETER	Sep 12, 1996	Substantially Equivalent	Bipore, Inc.
K960517	BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER	Apr 09, 1996	Substantially Equivalent	C.R. Bard, Inc.
K960501	ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER	Apr 09, 1996	Substantially Equivalent	Boston Scientific Corp
K955886	MEGA PTA BALLOON CATHETER	Mar 11, 1996	Substantially Equivalent	Cordis Corp.
K952884	NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER	Feb 21, 1996	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K953298	MS CLASSIQUE BALLOON DIATATION CATHETER	Feb 08, 1996	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K953608	NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER	Dec 20, 1995	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K953569	COURIER BALLOON DILATATION CATHETER	Dec 20, 1995	Substantially Equivalent	Boston Scientific Corp
K954313	FOCUS PC BALLOON DILATATION CATHETER	Dec 01, 1995	Substantially Equivalent	Cardio-Dynamics, Inc.
K952063	XXL BALLON DILATATION CATHETER	Nov 14, 1995	Substantially Equivalent	Boston Scientific Corp
K953602	SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER	Oct 18, 1995	Substantially Equivalent	Boston Scientific Corp
K945693	CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER	Aug 17, 1995	Substantially Equivalent	Cardiovascular Dynamics, Inc.
K951248	BRAUN PTA BALLOON CATHETER	Jun 22, 1995	Substantially Equivalent	B.Braun Medical, Inc.
K952064	FOCUS BALLOON DILATATION CATHETER	Jun 21, 1995	Substantially Equivalent	Cardiovascular Dynamics, Inc.
K950119	OPTA 5(TM) 5F PTA BALLOON CATHETER	May 17, 1995	Substantially Equivalent	Cordis Corp.
K944989	NOPROFILE OLBERT CATHETER SYSTEM	Apr 26, 1995	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K946052	POWERFLEX(TM) 5F PTA BALLOON CATHETER	Mar 03, 1995	Substantially Equivalent	Cordis Corp.
K945943	CVD PERIFLOW(TM) BALLOON DILATATION CATHETER	Feb 24, 1995	Substantially Equivalent	Cardio-Dynamics, Inc.
K945465	CVD SMALL VESSEL BALLOON DILATATION CATHETER	Dec 20, 1994	Substantially Equivalent	Cardiovascular Dynamics, Inc.
K944016	FOCUS BALLOON DILATATION CATHETER	Dec 20, 1994	Substantially Equivalent	Cardiovascular Dynamics, Inc.
K944815	SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER	Nov 14, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K942400	BARD PERIPHERAL BALLOON DILATATION CATHETER	Nov 07, 1994	Substantially Equivalent	C.R. Bard, Inc.
K942635	MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM	Nov 01, 1994	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K942094	CORDIS SAVVY PTA BALLOON CATHETER	Nov 01, 1994	Substantially Equivalent	Cordis Corp.
K942293	MS CLASSIQUE BALLOON CATHETER	Oct 18, 1994	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K941706	OPTI-PLAST ANGIOPLASTY CATHETER	Oct 18, 1994	Substantially Equivalent	Vas-Cath, Inc.
K943298	MS CLASSIQUE BALLOON CATHETER	Sep 08, 1994	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K942154	SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS	Aug 18, 1994	Substantially Equivalent	Boston Scientific Scimed, Inc.
K942150	CVD SMALL VESSEL BALLOON DILATION CATHETER	Aug 02, 1994	Substantially Equivalent	Cardio-Dynamics, Inc.
K940868	CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION	Jul 12, 1994	Substantially Equivalent	Cordis Corp.
K930745	BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER	May 19, 1994	Substantially Equivalent	B.Braun Medical, Inc.
K940063	MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS	Mar 29, 1994	Substantially Equivalent	Medtronics Interventional Vascular
K925485	VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER	Mar 10, 1994	Substantially Equivalent	Vas-Cath, Inc.
K935501	SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING	Jan 27, 1994	Substantially Equivalent	Scimed Peripheral Interventions
K934378	SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER	Jan 18, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K934411	MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE	Jan 07, 1994	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K934793	SCIMED MAVERICK	Jan 05, 1994	Substantially Equivalent	Scimed Peripheral Interventions
K933236	CORDIS OPTA 5(TM), MODIFICATION	Dec 27, 1993	Substantially Equivalent	Cordis Corp.
K931009	TYSHAK PERIPHERAL BALLOON DILATION CATHETER	Dec 21, 1993	Substantially Equivalent	NuMED, Inc.
K934433	VANTAGE DIALTAION CATHETER	Dec 09, 1993	Substantially Equivalent	Peripheral Systems Group
K934191	NEW BLUE MAX BALLOON DILATATION CATHETER	Dec 09, 1993	Substantially Equivalent	Boston Scientific Corp
K932537	SCIMED MAVERICK PTA CATHETER	Dec 08, 1993	Substantially Equivalent	Scimed Life Systems, Inc.
K924320	ULTRA THIN BALLOON DILATATION CATHETER	Nov 10, 1993	Substantially Equivalent	Boston Scientific Corp
K923611	ULTRA THIN BALLOON DILATATION CATHETER	Nov 04, 1993	Substantially Equivalent	Boston Scientific Corp
K933975	MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM	Oct 06, 1993	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K923947	MEADOX SURGIMED BALLOON CATHETER	Sep 30, 1993	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K933483	OPTI-PLAST 5F PTA CATHETERS	Sep 24, 1993	Substantially Equivalent	Vas-Cath, Inc.
K931384	AVE ALLIANCE DILATATION CATHETER	Sep 17, 1993	Substantially Equivalent	Applied Vascular Engineering, Inc.
K933183	SCIMED VIPER	Sep 09, 1993	Substantially Equivalent	Scimed Life Systems, Inc.
K926271	SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO	Jun 07, 1993	Substantially Equivalent	Schneider Intl., Ltd.
K925945	MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT	May 20, 1993	Substantially Equivalent	Scimed Life Systems, Inc.
K924358	ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED	May 20, 1993	Substantially Equivalent	Cook, Inc.
K921706	MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R)	May 20, 1993	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K923638	ACESSORY PACK	Feb 08, 1993	Substantially Equivalent	Medtronics Interventional Vascular
K921254	BLUE MAX II BALLOON DDILATATION CATHETER	Dec 03, 1992	Substantially Equivalent	Boston Scientific Corp
K922610	BALLOON DILATATION CATHETER	Nov 18, 1992	Substantially Equivalent	Boston Scientific Corp
K924276	SHORT TEGWIRE -- MODIFIED	Nov 10, 1992	Substantially Equivalent	Boston Scientific Corp
K924047	SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER	Nov 02, 1992	Substantially Equivalent	Boston Scientific Corp
K923826	PARAMETRIC PROCESS CONTROL	Oct 22, 1992	Substantially Equivalent	Scimed Life Systems, Inc.
K921577	SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER	Oct 16, 1992	Substantially Equivalent	Scimed Life Systems, Inc.
K915347	SCIMED VIPER CATHETER	Aug 17, 1992	Substantially Equivalent	Scimed
K921856	TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH.	Jul 21, 1992	Substantially Equivalent	Schneider Intl., Ltd.
K921943	SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL	Jun 17, 1992	Substantially Equivalent	Schneider Intl., Ltd.
K915895	STEALTH DILATION CATHETER SYSTEM (MODIFIED)	Jun 04, 1992	Substantially Equivalent	Target Therapeutics
K920547	ULTRA-THIN	May 06, 1992	Substantially Equivalent	Boston Scientific Corp
K915168	PROFLEX 5	Feb 19, 1992	Substantially Equivalent	Peripheral Systems Group
K915349	PTA BALLOON CATHETER	Feb 11, 1992	Substantially Equivalent	Schneider Intl., Ltd.
K914976	OPTI-PLAST 5F PTA CATHETERS, MODIFICATION	Jan 27, 1992	Substantially Equivalent	Vas-Cath, Inc.
K914500	OPTI-PLAST 5F PTA CATHETERS, MODIFICATION	Dec 31, 1991	Substantially Equivalent	Vas-Cath, Inc.
K913391	TEGWIRE (TM)	Nov 05, 1991	Substantially Equivalent	Boston Scientific Corp
K913689	SUB-4(TM), PERIPHERAL DILATATION CATHETER	Oct 16, 1991	Substantially Equivalent	Boston Scientific Corp
K913297	SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH	Oct 10, 1991	Substantially Equivalent	Schneider Intl., Ltd.
K910965	ECHOMARK CSI INTERFACE	Sep 17, 1991	Substantially Equivalent	Catheter Sciences Co.
K910822	BARD PERIPHERAL BALLOON DILATATION CATHETER	Aug 29, 1991	Substantially Equivalent	C.R. Bard, Inc.
K912317	SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH	Aug 22, 1991	Substantially Equivalent	Schneider Intl., Ltd.
K913112	OPTI-PLAST 5F PTA CATHETERS	Aug 16, 1991	Substantially Equivalent	Vas-Cath, Inc.
K912984	OPTI-PLAST 5F PTA CATHETERS, MODIFICATION	Aug 13, 1991	Substantially Equivalent	Vas-Cath, Inc.
K911870	SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH	Aug 12, 1991	Substantially Equivalent	Scimed Life Systems, Inc.
K905698	CORDIS OPTA 5	Jul 09, 1991	Substantially Equivalent	Cordis Corp.
K911639	OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE	Jun 11, 1991	Substantially Equivalent	Vas-Cath, Inc.
K911196	SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA)	Jun 10, 1991	Substantially Equivalent	Schneider Intl., Ltd.
K911215	GESCO PER-Q-CATH NEEDLE	Jun 06, 1991	Substantially Equivalent	Gesco Intl., Inc.
K911130	HEMOSTATIC Y CONNECTOR	Jun 06, 1991	Substantially Equivalent	Thomas Medical Products, Inc.
K911089	STEALTH CATHETER SYSTEM	May 29, 1991	Substantially Equivalent	Target Therapeutics
K904984	ADVANCE 418(TM)	Apr 12, 1991	Substantially Equivalent	Peripheral Systems Group
K911203	TEGWIRE (TM)	Apr 09, 1991	Substantially Equivalent	Boston Scientific Corp
K910996	OPTI-PLAST 5F PTA CATHETERS	Apr 09, 1991	Substantially Equivalent	Vas-Cath, Inc.
K910995	MEDI-TECH BALLOON DILATATION CATHETER	Apr 09, 1991	Substantially Equivalent	Boston Scientific Corp
K904410	MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)	Mar 25, 1991	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K896520	OWENS CATHETER	Mar 25, 1991	Substantially Equivalent	Boston Scientific Corp
K900677	ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER	Feb 22, 1991	Substantially Equivalent	Cook, Inc.
K910155	SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH	Feb 07, 1991	Substantially Equivalent	Scimed Life Systems, Inc.
K905773	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER	Jan 30, 1991	Substantially Equivalent	Mallinckrodt Medical
K905250	LOBOW	Jan 08, 1991	Substantially Equivalent	Perinatal Systems
K903417	VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH	Dec 05, 1990	Substantially Equivalent	Vas-Cath, Inc.
K902367	OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER	Dec 03, 1990	Substantially Equivalent	Vas-Cath, Inc.
K902317	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.	Dec 03, 1990	Substantially Equivalent	Mallinckrodt Medical
K903582	ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.	Nov 06, 1990	Substantially Equivalent	Catheter Sciences Co.
K900094	PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER	Oct 31, 1990	Substantially Equivalent	Boston Scientific Corp
K897106	MEDI-TECH DILATATION CATHETERS ULTRA THIN II	Oct 16, 1990	Substantially Equivalent	Boston Scientific Corp
K903606	GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER	Sep 27, 1990	Substantially Equivalent	North American Instrument Corp.
K902091	SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER	Sep 26, 1990	Substantially Equivalent	Schneider Intl., Ltd.
K902454	CATHSCANNER(R) PTA BALLOON DILATATION CATHETER	Aug 30, 1990	Substantially Equivalent	Endosonics Corp.
K897124	SMALL VESSEL BALLOON DILATATION CATHETER	Jul 17, 1990	Substantially Equivalent	Boston Scientific Corp
K901601	HOLLOW MOTOR DRIVE UNIT	Jul 06, 1990	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K901767	MODIFIED IVT PERIPHERAL ATHERECTOMY	Jun 28, 1990	Substantially Equivalent	Intensive Technology, Inc.
K901018	MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS	May 30, 1990	Substantially Equivalent	Boston Scientific Corp
K894250	LE PTA CATHETER	Mar 07, 1990	Substantially Equivalent	Baxter Healthcare Corp
K896403	MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM	Mar 06, 1990	Substantially Equivalent	Intensive Technology, Inc.
K895179	ACCESSOR PERIPHERAL DILATING GUIDE WIRE	Feb 28, 1990	Substantially Equivalent	Peripheral Systems Group
K894899	EXPANSION OF THE CORDIS PTA DILATATION CATHETER	Jan 26, 1990	Substantially Equivalent	Cordis Corp.
K894944	BALLOON DILATATION CATHETER	Jan 19, 1990	Substantially Equivalent	Peripheral Systems Group
K893411	STEALTH DILATION CATHETER SYSTEM	Sep 05, 1989	Substantially Equivalent	Target Therapeutics
K890405	USCI PTA BALLOON DILATATION CATHETER	Aug 17, 1989	Substantially Equivalent	C.R. Bard, Inc.
K890800	ROTATING HEMOSTATIC VALVE	Jun 12, 1989	Substantially Equivalent	Datascope Corp.
K884327	EXCEL Y-CONNECTOR CAT. #E-201	Apr 19, 1989	Substantially Equivalent	Medical Profiles, Inc.
K890325	USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP	Mar 15, 1989	Substantially Equivalent	C.R. Bard, Inc.
K885247	STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR	Mar 10, 1989	Substantially Equivalent	Baxter Healthcare Corp
K882826	SOFTRAC-PTA PERIPHERAL DILATATION CATHETER	Jan 24, 1989	Substantially Equivalent	Schneider-Shilley (Usa)
K884481	CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE	Jan 10, 1989	Substantially Equivalent	Mallinckroot, Inc.
K882925	ACS SCHWARTEN XT BALLOON DILATATION CATHETER	Sep 28, 1988	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K883346	SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F	Sep 26, 1988	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K882052	OMEGA NV(TM) BALLOON DILATATION CATHETER	Sep 14, 1988	Substantially Equivalent	Cook, Inc.
K880612	CORDIS PTA DILATATION CATHETERS	Jul 28, 1988	Substantially Equivalent	Cordis Corp.
K875175	MODIFIED PERIPHERAL DILATATION CATHETERS	Jul 28, 1988	Substantially Equivalent	Schneider-Shilley (Usa)
K881088	ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)	May 31, 1988	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K881197	SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER	May 16, 1988	Substantially Equivalent	Schneider-Shilley (Usa)
K880298	PERIPHERAL DILATATION CATHETER	Apr 22, 1988	Substantially Equivalent	Medi-Tech, Inc.
K880194	KENSEY CATHETER	Apr 18, 1988	Substantially Equivalent	Theratek, Inc.
K880158	ANGIOPLASTY BALLOON INFLATION DEVICE	Mar 22, 1988	Substantially Equivalent	L.O.N. Research, Inc.
K875064	SCIMED INFLATION DEVICE, MODEL SM 2000	Feb 29, 1988	Substantially Equivalent	Scimed Life Systems, Inc.
K874706	MODIFIED SIMPSON PERIPHERAL ATHEROCATH	Jan 04, 1988	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K871796	NUMED PTA CATHETERS	Dec 03, 1987	Substantially Equivalent	NuMED, Inc.
K872542	SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER	Sep 14, 1987	Substantially Equivalent	Angiomedics, Inc.
K870215	DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)	Aug 12, 1987	Substantially Equivalent	Cook, Inc.
K871011	SIMPSON PERIPHERAL ATHEROCATH(TM)	May 14, 1987	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K862550	OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE	Sep 02, 1986	Substantially Equivalent	Meadox Surgimed, Inc.
K862467	SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR	Aug 11, 1986	Substantially Equivalent	Shiley, Inc.
K854319	SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER	Mar 31, 1986	Substantially Equivalent	Shiley, Inc.
K853746	ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO	Oct 21, 1985	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K844913	CORDIS PTA CATHETER-PERCUTANEOUS CATHETER	Aug 20, 1985	Substantially Equivalent	Cordis Corp.
K851854	ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO	Aug 05, 1985	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K851848	PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER	Jul 19, 1985	Substantially Equivalent	Mansfield Scientific, Inc.
K851080	GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE	Jun 20, 1985	Substantially Equivalent	G V Medical, Inc.
K844972	ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER	May 16, 1985	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K850760	MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER	Apr 10, 1985	Substantially Equivalent	Scimed Life Systems, Inc.
K850075	SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT	Apr 10, 1985	Substantially Equivalent	Scimed Life Systems, Inc.
K843880	LOW PROFILE STEERABLE BALLOON DILATION	Nov 27, 1984	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K843383	MEDI-TECH DILATATION CATHETERS	Oct 24, 1984	Substantially Equivalent	Medi-Tech, Inc.
K841961	MILLS OPERATIVE PERIPHERAL ANGIOPLASTY	Oct 23, 1984	Substantially Equivalent	Scimed Life Systems, Inc.
K843501	BALLOON DILATION CATHETER	Oct 04, 1984	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K842556	ADVANCED CARDIOVASCULAR BALLOON DILATA	Aug 10, 1984	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K834429	PERIPHERAL DILATATION ANGIOPLASTY-CATH	Aug 10, 1984	Substantially Equivalent	American Edwards Laboratories
K834220	HYBRID PERIPHERAL DILATION CATHETER	Jan 27, 1984	Substantially Equivalent	American Edwards Laboratories
K833616	OLBERT CATHETER SYSTEM	Dec 26, 1983	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K833248	LOW PROFILE STEERABLE-INTRAOPERATIVE	Dec 22, 1983	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K832474	FOGARTY-CHIN PERIPHERAL DILATION CATH	Sep 29, 1983	Substantially Equivalent	American Edwards Laboratories
K831659	FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE	Aug 12, 1983	Substantially Equivalent	American Edwards Laboratories
K831403	LOW PROFILE STEERABLE BALLOON DILATA	Jun 08, 1983	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K830733	FORGARTY CHIN PERIPHERAL INTRAOPERATIVE	Apr 18, 1983	Substantially Equivalent	American Edwards Laboratories
K830608	USCI GRUNTZIG DILACA BALLOON DILATION	Mar 24, 1983	Substantially Equivalent	C.R. Bard, Inc.
K822245	INDEFLATOR	Aug 31, 1982	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K813331	P51 ANGIOPLASTY PRESSURE TRANSDUCER	Dec 29, 1981	Substantially Equivalent	Konigsberg Instruments, Inc.
K812168	CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH.	Aug 31, 1981	Substantially Equivalent	Cordis Corp.
K803057	FOGARTY BALLON ANGIOPLASTY CATHETERS	Jan 13, 1981	Substantially Equivalent	American Edwards Laboratories