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MCW

146 FDA 510(k) clearances · Product code

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RecordFirmDate
THROMCAT THROMBECTOMY CATHETER SYSTEM (K072195)Kensey Nash Corp.2007-08-23
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K071350)Cardiovascular Systems, Inc.2007-08-22
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K061188)Foxhollow Technologies, Inc.2006-10-23
MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 (K061063)Foxhollow Technologies, Inc.2006-05-18
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K060904)Rex Medical, L.P.2006-04-28
THROMCAT THROMBECTOMY CATHETER SYSTEM (K060016)Kensey Nash Corp.2006-04-25
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, (K053460)Fox Hollow Technologies2006-01-13
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 (K043553)Fox Hollow Technologies2005-02-18
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K041630)Cardiovascular Systems Incorporated2005-01-31
X-SIZER CATHETER SYSTEM (K021096)Ev3 Corporation2004-09-08
CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT (K040252)Rex Medical2004-02-26
SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 (K033997)Bacchus Vascular, Inc.2004-02-04
CLEANER II ROTATIONAL THROMBECTOMY SYSTEM (K033793)Rex Medical2003-12-16
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 (K030504)Idev Technologies, Inc.2003-09-16
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 (K024243)Fox Hollow Technologies2003-06-20
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K031610)Rex Medical2003-05-27
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM (K022640)Bacchus Vascular, Inc.2002-12-02
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL (K013473)Xtrak Medical, Inc.2002-03-06
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 (K003570)Bacchus Vascular, Inc.2001-06-06
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD (K993816)Baxter Edwards2000-05-04
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 (K993564)Possis Medical, Inc.2000-04-28
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER (K993648)Boston Scientific Corporation Northwest Technology1999-11-24
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 (K990829)Arrow Intl., Inc.1999-05-04
OASIS THROMBECTOMY CATHETER SYSTEM (K982363)Boston Scientific Corp1999-02-23
AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 (K982657)Microvena Corp.1998-11-18
THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) (K973669)Micro Therapeutics, Inc.1998-02-06
GELBFISH ENDO-VAC SYSTEM (K970233)Gary A. Gelbfish1997-10-08
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) (K971984)Microvena Corp.1997-09-19
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER (K970296)Boston Scientific Corp1997-08-29
THROMBOLYTIC BRUSH CATHETER (K963925)Micro Therapeutics, Inc.1997-08-08
ARROW-TREROTOLA PTD CATHETER (K970080)Arrow Intl., Inc.1997-07-25
POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P (K960970)Possis Medical, Inc.1996-12-03
THE AMPLATZ THROMBECTOMY DEVICE (K954205)Microvena Corp.1996-08-13
ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE (K960379)Heart Technology Mfg., Inc.1996-04-25
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY (K954604)Heart Technology Mfg., Inc.1996-01-18
ROTABLATOR ROTATIONAL ANGIOPLASTY (K953997)Heart Technology Mfg., Inc.1995-12-22
GRAFT THROMBECTOMY INSTRUMENTS (K942457)Intramed Laboratories, Inc.1995-02-07
MICROTRACK (K935929)Devices For Vascular Intervention, Inc.1994-03-10
ROTABLATOR, MODIFICATION (K933238)Heart Technology, Inc.1993-08-24
INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM (K922970)Intensive Technology, Inc.1993-01-13
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (K924712)Hearing Tech, Inc.1992-12-08
HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER (K920707)Devices For Vascular Intervention, Inc.1992-11-23
TRAC-WRIGHT TRAC 10 CATHETER (K915238)Dow Corning Wright1992-02-19
HEART TECHNOLOGY ROTABLATOR WIRECLIP (K913450)Heart Technology, Inc.1991-09-06
THERATEK GROUP EXCHANGE CATHETER (K904680)Dow Corning Wright1990-12-27
ROTABLATOR (K901206)Heart Technology, Inc.1990-09-14
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