ClearanceBrief
Panels › Cardiovascular › Product code MCW · Class 2

Catheter, Peripheral, Atherectomy

Regulation 870.4875

1510(k)s in 12 months (146 all time)
0recalls in 12 months (34 all time)
33recalls that name a 510(k)
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Top companies in MCW

Company510(k)sRecalls
Cardiovascular Systems Incorporated2112
Pathway Medical Technologies, Inc.160
Spectranetics105
Ev3 Corporation47
Avinger, Inc.100
Eximo Medical80
Rex Medical80
Boston Scientific Corp51
Volcano Atheromed, Inc.60
Cardio Flow Inc.,40
Decided510(k)Device and applicantCode
Aug 23, 2007K072195THROMCAT THROMBECTOMY CATHETER SYSTEM
Kensey Nash Corp.
MCW
Aug 22, 2007K071350DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
Cardiovascular Systems, Inc.
MCW
Oct 23, 2006K061188SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
Foxhollow Technologies, Inc.
MCW
May 18, 2006K061063MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
Foxhollow Technologies, Inc.
MCW
Apr 28, 2006K060904CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Rex Medical, L.P.
MCW
Apr 25, 2006K060016THROMCAT THROMBECTOMY CATHETER SYSTEM
Kensey Nash Corp.
MCW
Jan 13, 2006K053460MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,
Fox Hollow Technologies
MCW
Feb 18, 2005K043553SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
Fox Hollow Technologies
MCW
Jan 31, 2005K041630ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Cardiovascular Systems Incorporated
MCW
Sep 8, 2004K021096X-SIZER CATHETER SYSTEM
Ev3 Corporation
MCW
Feb 26, 2004K040252CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT
Rex Medical
MCW
Feb 4, 2004K033997SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
Bacchus Vascular, Inc.
MCW
Dec 16, 2003K033793CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
Rex Medical
MCW
Sep 16, 2003K030504AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
Idev Technologies, Inc.
MCW
Jun 20, 2003K024243REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406
Fox Hollow Technologies
MCW
May 27, 2003K031610REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Rex Medical
MCW
Dec 2, 2002K022640SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
Bacchus Vascular, Inc.
MCW
Mar 6, 2002K013473XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL
Xtrak Medical, Inc.
MCW
Jun 6, 2001K003570BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
Bacchus Vascular, Inc.
MCW
May 4, 2000K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
Baxter Edwards
MCW
Apr 28, 2000K993564POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
Possis Medical, Inc.
MCW
Nov 24, 1999K993648ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
Boston Scientific Corporation Northwest Technology
MCW
May 4, 1999K990829ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
Arrow Intl., Inc.
MCW
Feb 23, 1999K982363OASIS THROMBECTOMY CATHETER SYSTEM
Boston Scientific Corp
MCW
Nov 18, 1998K982657AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
Microvena Corp.
MCW
Feb 6, 1998K973669THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
Micro Therapeutics, Inc.
MCW
Oct 8, 1997K970233GELBFISH ENDO-VAC SYSTEM
Gary A. Gelbfish
MCW
Sep 19, 1997K971984AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
Microvena Corp.
MCW
Aug 29, 1997K970296ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
Boston Scientific Corp
MCW
Aug 8, 1997K963925THROMBOLYTIC BRUSH CATHETER
Micro Therapeutics, Inc.
MCW
Jul 25, 1997K970080ARROW-TREROTOLA PTD CATHETER
Arrow Intl., Inc.
MCW
Dec 3, 1996K960970POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P
Possis Medical, Inc.
MCW
Aug 13, 1996K954205THE AMPLATZ THROMBECTOMY DEVICE
Microvena Corp.
MCW
Apr 25, 1996K960379ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
Heart Technology Mfg., Inc.
MCW
Jan 18, 1996K954604ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY
Heart Technology Mfg., Inc.
MCW
Dec 22, 1995K953997ROTABLATOR ROTATIONAL ANGIOPLASTY
Heart Technology Mfg., Inc.
MCW
Feb 7, 1995K942457GRAFT THROMBECTOMY INSTRUMENTS
Intramed Laboratories, Inc.
MCW
Mar 10, 1994K935929MICROTRACK
Devices For Vascular Intervention, Inc.
MCW
Aug 24, 1993K933238ROTABLATOR, MODIFICATION
Heart Technology, Inc.
MCW
Jan 13, 1993K922970INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM
Intensive Technology, Inc.
MCW
Dec 8, 1992K924712ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Hearing Tech, Inc.
MCW
Nov 23, 1992K920707HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER
Devices For Vascular Intervention, Inc.
MCW
Feb 19, 1992K915238TRAC-WRIGHT TRAC 10 CATHETER
Dow Corning Wright
MCW
Sep 6, 1991K913450HEART TECHNOLOGY ROTABLATOR WIRECLIP
Heart Technology, Inc.
MCW
Dec 27, 1990K904680THERATEK GROUP EXCHANGE CATHETER
Dow Corning Wright
MCW
Sep 14, 1990K901206ROTABLATOR
Heart Technology, Inc.
MCW

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