Product Code: MCW FDA class 2 21 CFR 870.4875

Catheter, Peripheral, Atherectomy

Cardiovascular

The peripheral atherectomy catheter is a cardiovascular device used to remove atherosclerotic plaque from peripheral arteries through a minimally invasive catheter-based approach, restoring blood flow in patients with peripheral arterial disease. It is classified as FDA Class II under 21 CFR 870.4875 within the Cardiovascular specialty, requiring 510(k) premarket clearance. The product code is MCW and the device is not implanted. Full GMP quality system requirements apply.

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510(k)s

146

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MCW
Device Class: FDA class 2
Regulation Number: 870.4875
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 146 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260244	Auryon Atherectomy System	Apr 10, 2026	Substantially Equivalent	Eximo Medical
K250723	FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)	Apr 25, 2025	Substantially Equivalent	Cardio Flow Inc.,
K250385	Turbo-Elite Laser Atherectomy Catheter	Mar 13, 2025	Substantially Equivalent	Spectranetics
K242757	Rotarex Atherectomy System	Jan 30, 2025	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K242947	FreedomFlow Orbital Circumferential Atherectomy System	Nov 05, 2024	Substantially Equivalent	Cardio Flow Inc.,
K241553	Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating	Jun 27, 2024	Substantially Equivalent	Eximo Medical, Ltd.
K233483	FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)	Feb 15, 2024	Substantially Equivalent	Cardio Flow Inc.,
K233668	Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)	Dec 15, 2023	Substantially Equivalent	Eximo Medical, Ltd.
K231538	FreedomFlow Orbital Circumferential Atherectomy System	Sep 27, 2023	Substantially Equivalent	Cardio Flow Inc.,
K230709	Auryon Atherectomy System	Jun 09, 2023	Substantially Equivalent	Eximo Medical, Ltd.
K230005	Pantheris LV Atherectomy Catheter	Jun 06, 2023	Substantially Equivalent	Avinger, Inc.
K222837	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	Dec 08, 2022	Substantially Equivalent	Spectranetics, Inc.
K220116	Auryon Atherectomy Catheters	Sep 26, 2022	Substantially Equivalent	Eximo Medical, Ltd.
K220962	ROTAPRO Rotational Atherectomy System	Sep 06, 2022	Substantially Equivalent	Boston Scientific Corporation
K221077	Auryon Atherectomy System	Jun 09, 2022	Substantially Equivalent	Eximo Medical, Ltd.
K220568	Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series	Apr 27, 2022	Substantially Equivalent	Cardiovascualr Systems, Inc.
K220109	DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System	Mar 01, 2022	Substantially Equivalent	Cardiovascular Systems, Inc.
K212351	Revolution Peripheral Atherectomy System	Dec 15, 2021	Substantially Equivalent	Rex Medical, L.P.
K212047	Pantheris System	Nov 16, 2021	Substantially Equivalent	Avinger, Inc.
K211738	Rotarex Atherectomy System	Sep 14, 2021	Substantially Equivalent	C.R. Bard, Inc.
K210586	Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system	Sep 14, 2021	Substantially Equivalent	Cardiovascular Systems, Inc.
K212027	TurboHawk Plus Directional Atherectomy System	Aug 24, 2021	Substantially Equivalent	Medtronic, Inc.
K211518	2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System	Jun 14, 2021	Substantially Equivalent	Volcano Atheromed, Inc.
K202835	Auryon Atherectomy System	Dec 02, 2020	Substantially Equivalent	Eximo Medical, Ltd.
K203008	DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System	Nov 19, 2020	Substantially Equivalent	Cardiovascular Systems, Inc.
K191419	Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire	Sep 12, 2019	Substantially Equivalent	Rex Medical, L.P.
K190634	Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System	Jul 02, 2019	Substantially Equivalent	Cardiovascular Systems, Inc.
K182341	Pantheris SV	Apr 09, 2019	Substantially Equivalent	Avinger, Inc.
K182972	Phoenix Atherectomy System	Dec 20, 2018	Substantially Equivalent	Volcano Atheromed, Inc.
K181877	Phoenix 2.4mm Atherectomy Plus System	Dec 17, 2018	Substantially Equivalent	Volcano Atheromed, Inc.
K182397	Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series	Dec 13, 2018	Substantially Equivalent	Cardiovascular Systems, Inc.
K181642	B-Laser Atherectomy System	Oct 05, 2018	Substantially Equivalent	Eximo Medical, Ltd.
K173862	Pantheris System	May 22, 2018	Substantially Equivalent	Avinger, Inc.
K180416	ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System	Apr 17, 2018	Substantially Equivalent	Cardiovascular Systems, Inc.
K172315	Straub Endovascular System	Apr 12, 2018	Substantially Equivalent	Straub Medical AG
K180694	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	Apr 05, 2018	Substantially Equivalent	Spectranetics, Inc.
K172687	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	Nov 27, 2017	Substantially Equivalent	Spectranetics, Inc.
K172236	Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled	Oct 30, 2017	Substantially Equivalent	Avinger, Inc.
K172386	1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System	Aug 24, 2017	Substantially Equivalent	Volcano Atheromed, Inc.
K170191	SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System	Jun 16, 2017	Substantially Equivalent	Medtronic Vascular, Inc.
K170792	Diamondback 360 Peripheral Orbital Atherectomy System	Jun 09, 2017	Substantially Equivalent	Cardiovascular Systems, Inc.
K170059	Spectranetics Turbo-Elite Laser Atherectomy Catheters	Apr 07, 2017	Substantially Equivalent	Spectranetics, Inc.
K162561	Turbo-Power (2.0mm) Laser Atherectomy Catheters	Jan 05, 2017	Substantially Equivalent	Spectranetics, Inc.
K163264	Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled	Dec 21, 2016	Substantially Equivalent	Avinger, Inc.
K162326	Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled	Oct 18, 2016	Substantially Equivalent	Avinger, Inc.
K161361	HawkOne Directional Atherectomy System	Oct 14, 2016	Substantially Equivalent	Medtronic Vascular, Inc.
K160827	Pantheris Catheter	Apr 21, 2016	Substantially Equivalent	Avinger, Inc.
K153460	Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)	Mar 01, 2016	Substantially Equivalent	Avinger, Inc.
K152181	Turbo-Power Laser Atherectomy Catheter	Nov 12, 2015	Substantially Equivalent	Spectranetics, Inc.
K152694	Diamondback 360 Peripheral Orbital Atherectomy System	Oct 21, 2015	Substantially Equivalent	Cardiovascular Systems, Inc.
K152275	Pantheris System	Oct 14, 2015	Substantially Equivalent	Avinger, Inc.
K151260	ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD	Jun 10, 2015	Substantially Equivalent	Cardiovascular System, Inc.
K151145	2.4mm X 127 cm Phoenix Atherectomy Deflecting System	May 26, 2015	Substantially Equivalent	Volcano Atheromed, Inc.
K150732	Diamondback 360 Peripheral Orbital Atherectomy System	Apr 13, 2015	Substantially Equivalent	Cardiovascular Systems, Inc.
K143328	1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip	Dec 19, 2014	Substantially Equivalent	Volcano Atheromed, Inc.
K141801	HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM	Oct 16, 2014	Substantially Equivalent	Covidien, LLC
K133023	JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6	Aug 27, 2014	Substantially Equivalent	Medrad, Inc.
K140944	1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP	Aug 22, 2014	Substantially Equivalent	Atheromed, Inc.
K140775	TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM	Jul 23, 2014	Substantially Equivalent	Spectranetics Corporation
K133999	DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM	Feb 28, 2014	Substantially Equivalent	Cardiovascular Systems, Inc.
K132682	PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA	Jan 17, 2014	Substantially Equivalent	Atheromed, Inc.
K133566	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS	Dec 20, 2013	Substantially Equivalent	Boston Scientific Corp
K133399	DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM	Nov 22, 2013	Substantially Equivalent	Cardiovascular Systems Incorporated
K131092	STEALTH 360 ORBITAL PAD SYSTEM	Jun 24, 2013	Substantially Equivalent	Cardio Systems, Inc.
K130637	JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM	Apr 10, 2013	Substantially Equivalent	Medrad, Inc.
K123632	2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035	Jan 25, 2013	Substantially Equivalent	Spectranetics Corp.
K122987	STEALTH 360 ORBITAL PAD SYSTEM	Oct 25, 2012	Substantially Equivalent	Cardiovascular Systems, Inc.
K122916	JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM	Oct 19, 2012	Substantially Equivalent	Medrad, Inc.
K121774	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS	Sep 13, 2012	Substantially Equivalent	Boston Scientific Corp
K120346	CLEANER ROTATIONAL THROMBECTOMY SYSTEM	Jun 01, 2012	Substantially Equivalent	Rex Medical
K120242	JETSTREAM NAVITUS L SYSTEM	Feb 24, 2012	Substantially Equivalent	Pathway Medical Technologies, Inc.
K111723	TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM	Oct 27, 2011	Substantially Equivalent	Ev3, Inc.
K111388	DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM	Jul 26, 2011	Substantially Equivalent	Cardiovascular Systems, Inc.
K111229	JETSTREAM G3 (R) SF 1.6 SYSTEM	Jun 01, 2011	Substantially Equivalent	Pathway Medical Technologies, Inc.
K110626	JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM	Apr 20, 2011	Substantially Equivalent	Pathway Medical Technologies, Inc.
K110389	STEALTH 360 ORBITAL PAD SYSTEM	Mar 11, 2011	Substantially Equivalent	Cardiovascular Systems, Inc.
K103618	TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM	Jan 05, 2011	Substantially Equivalent	Ev3, Inc.
K101334	JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON	Jun 11, 2010	Substantially Equivalent	Pathway Medical Technologies, Inc.
K101221	JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100	Jun 02, 2010	Substantially Equivalent	Pathway Medical Technologies, Inc.
K100462	JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100	May 19, 2010	Substantially Equivalent	Pathway Medical Technologies, Inc.
K091029	CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)	Feb 18, 2010	Substantially Equivalent	Rex Medical
K094036	TURBO-TANDEM SYSTEM MODEL 472-110	Jan 25, 2010	Substantially Equivalent	Spectranetics Corp.
K093918	JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)	Jan 21, 2010	Substantially Equivalent	Pathway Medical Technologies, Inc.
K093456	JETSTREAM G3 SYSTEM	Dec 01, 2009	Substantially Equivalent	Pathway Medical Technologies, Inc.
K093301	TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM	Nov 06, 2009	Substantially Equivalent	Ev3, Inc.
K092332	JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)	Sep 03, 2009	Substantially Equivalent	Pathway Medical Technologies, Inc.
K091509	JETSTREAM G2 NXT SYSTEM, MODEL PV20300	Jun 19, 2009	Substantially Equivalent	Pathway Medical Technologies, Inc.
K090521	DIAMONDBACK 360 DBX	Mar 20, 2009	Substantially Equivalent	Cardiovascular Systems, Inc.
K090325	JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)	Mar 11, 2009	Substantially Equivalent	Pathway Medical Technologies, Inc.
K083489	JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300	Jan 23, 2009	Substantially Equivalent	Pathway Medical Technologies, Inc.
K083837	JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)	Jan 13, 2009	Substantially Equivalent	Pathway Medical Technologies, Inc.
K082981	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT	Oct 31, 2008	Substantially Equivalent	Cardiovascular Systems, Inc.
K082664	JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100	Oct 06, 2008	Substantially Equivalent	Pathway Medical Technologies, Inc.
K082186	MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM	Aug 29, 2008	Substantially Equivalent	Pathway Medical Technologies, Inc.
K081944	MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM	Aug 14, 2008	Substantially Equivalent	Cardio Systems, Inc.
K081328	PATHWAY PV ATHERECTOMY SYSTEM	Jul 17, 2008	Substantially Equivalent	Pathway Medical Technologies, Inc.
K071432	SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE	Feb 12, 2008	Substantially Equivalent	Fox Hollow Technologies
K072748	MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM	Nov 09, 2007	Substantially Equivalent	Cardiovascular Systems, Inc.
K072800	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM	Oct 25, 2007	Substantially Equivalent	Cardiovascular Systems, Inc.
K071427	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS	Aug 30, 2007	Substantially Equivalent	Cardiovascular Systems, Inc.
K072195	THROMCAT THROMBECTOMY CATHETER SYSTEM	Aug 23, 2007	Substantially Equivalent	Kensey Nash Corp.
K071350	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM	Aug 22, 2007	Substantially Equivalent	Cardiovascular Systems, Inc.
K061188	SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM	Oct 23, 2006	Substantially Equivalent	Foxhollow Technologies, Inc.
K061063	MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300	May 18, 2006	Substantially Equivalent	Foxhollow Technologies, Inc.
K060904	CLEANER ROTATIONAL THROMBECTOMY SYSTEM	Apr 28, 2006	Substantially Equivalent	Rex Medical, L.P.
K060016	THROMCAT THROMBECTOMY CATHETER SYSTEM	Apr 25, 2006	Substantially Equivalent	Kensey Nash Corp.
K053460	MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,	Jan 13, 2006	Substantially Equivalent	Fox Hollow Technologies
K043553	SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300	Feb 18, 2005	Substantially Equivalent	Fox Hollow Technologies
K041630	ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS	Jan 31, 2005	Substantially Equivalent	Cardiovascular Systems Incorporated
K021096	X-SIZER CATHETER SYSTEM	Sep 08, 2004	Substantially Equivalent	Ev3 Corporation
K040252	CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT	Feb 26, 2004	Substantially Equivalent	Rex Medical
K033997	SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110	Feb 04, 2004	Substantially Equivalent	Bacchus Vascular, Inc.
K033793	CLEANER II ROTATIONAL THROMBECTOMY SYSTEM	Dec 16, 2003	Substantially Equivalent	Rex Medical
K030504	AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060	Sep 16, 2003	Substantially Equivalent	Idev Technologies, Inc.
K024243	REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406	Jun 20, 2003	Substantially Equivalent	Fox Hollow Technologies
K031610	REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM	May 27, 2003	Substantially Equivalent	Rex Medical
K022640	SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM	Dec 02, 2002	Substantially Equivalent	Bacchus Vascular, Inc.
K013473	XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL	Mar 06, 2002	Substantially Equivalent	Xtrak Medical, Inc.
K003570	BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755	Jun 06, 2001	Substantially Equivalent	Bacchus Vascular, Inc.
K993816	BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD	May 04, 2000	Substantially Equivalent	Baxter Edwards
K993564	POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002	Apr 28, 2000	Substantially Equivalent	Possis Medical, Inc.
K993648	ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER	Nov 24, 1999	Substantially Equivalent	Boston Scientific Corporation Northwest Technology
K990829	ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65	May 04, 1999	Substantially Equivalent	Arrow Intl., Inc.
K982363	OASIS THROMBECTOMY CATHETER SYSTEM	Feb 23, 1999	Substantially Equivalent	Boston Scientific Corp
K982657	AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100	Nov 18, 1998	Substantially Equivalent	Microvena Corp.
K973669	THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)	Feb 06, 1998	Substantially Equivalent	Micro Therapeutics, Inc.
K970233	GELBFISH ENDO-VAC SYSTEM	Oct 08, 1997	Unknown	Gary A. Gelbfish
K971984	AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)	Sep 19, 1997	Substantially Equivalent	Microvena Corp.
K970296	ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER	Aug 29, 1997	Substantially Equivalent	Boston Scientific Corp
K963925	THROMBOLYTIC BRUSH CATHETER	Aug 08, 1997	Substantially Equivalent	Micro Therapeutics, Inc.
K970080	ARROW-TREROTOLA PTD CATHETER	Jul 25, 1997	Substantially Equivalent	Arrow Intl., Inc.
K960970	POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P	Dec 03, 1996	Substantially Equivalent	Possis Medical, Inc.
K954205	THE AMPLATZ THROMBECTOMY DEVICE	Aug 13, 1996	Substantially Equivalent	Microvena Corp.
K960379	ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE	Apr 25, 1996	Substantially Equivalent	Heart Technology Mfg., Inc.
K954604	ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY	Jan 18, 1996	Substantially Equivalent	Heart Technology Mfg., Inc.
K953997	ROTABLATOR ROTATIONAL ANGIOPLASTY	Dec 22, 1995	Substantially Equivalent	Heart Technology Mfg., Inc.
K942457	GRAFT THROMBECTOMY INSTRUMENTS	Feb 07, 1995	Substantially Equivalent	Intramed Laboratories, Inc.
K935929	MICROTRACK	Mar 10, 1994	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K933238	ROTABLATOR, MODIFICATION	Aug 24, 1993	Substantially Equivalent	Heart Technology, Inc.
K922970	INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM	Jan 13, 1993	Substantially Equivalent	Intensive Technology, Inc.
K924712	ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM	Dec 08, 1992	Substantially Equivalent	Hearing Tech, Inc.
K920707	HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER	Nov 23, 1992	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K915238	TRAC-WRIGHT TRAC 10 CATHETER	Feb 19, 1992	Substantially Equivalent	Dow Corning Wright
K913450	HEART TECHNOLOGY ROTABLATOR WIRECLIP	Sep 06, 1991	Substantially Equivalent	Heart Technology, Inc.
K904680	THERATEK GROUP EXCHANGE CATHETER	Dec 27, 1990	Substantially Equivalent	Dow Corning Wright
K901206	ROTABLATOR	Sep 14, 1990	Substantially Equivalent	Heart Technology, Inc.