FDA 510(k) Applications for Medical Device Product Code "MCW"
(Catheter, Peripheral, Atherectomy)

FDA 510(k) Number Applicant Device Name Decision Date
K990829 ARROW INTL., INC. ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 05/04/1999
K970080 ARROW INTL., INC. ARROW-TREROTOLA PTD CATHETER 07/25/1997
K140944 ATHEROMED INC 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP 08/22/2014
K132682 ATHEROMED INC PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA 01/17/2014
K162326 Avinger, Inc Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled 10/18/2016
K160827 AVINGER, INC. Pantheris Catheter 04/21/2016
K172236 Avinger, Inc. Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled 10/30/2017
K163264 Avinger, Inc. Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled 12/21/2016
K153460 AVINGER, INC. Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) 03/01/2016
K152275 Avinger, Inc. Pantheris System 10/14/2015
K173862 Avinger, Inc. Pantheris System 05/22/2018
K003570 BACCHUS VASCULAR, INC. BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 06/06/2001
K022640 BACCHUS VASCULAR, INC. SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM 12/02/2002
K033997 BACCHUS VASCULAR, INC. SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 02/04/2004
K993816 BAXTER EDWARDS BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD 05/04/2000
K982363 BOSTON SCIENTIFIC CORP. OASIS THROMBECTOMY CATHETER SYSTEM 02/23/1999
K970296 BOSTON SCIENTIFIC CORP. ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER 08/29/1997
K121774 BOSTON SCIENTIFIC CORP. ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS 09/13/2012
K133566 BOSTON SCIENTIFIC CORP. ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS 12/20/2013
K993648 BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER 11/24/1999
K081944 CARDIO SYSTEMS, INC. MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM 08/14/2008
K131092 CARDIO SYSTEMS, INC. STEALTH 360 ORBITAL PAD SYSTEM 06/24/2013
K151260 Cardiovascular System, Inc. ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD 06/10/2015
K152694 Cardiovascular Systems Inc. Diamondback 360 Peripheral Orbital Atherectomy System 10/21/2015
K182397 Cardiovascular Systems Inc. Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series 12/13/2018
K180416 Cardiovascular Systems Inc. ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System 04/17/2018
K133399 CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM 11/22/2013
K041630 CARDIOVASCULAR SYSTEMS INCORPORATED ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS 01/31/2005
K090521 CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 DBX 03/20/2009
K072800 CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM 10/25/2007
K071350 CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM 08/22/2007
K071427 CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS 08/30/2007
K082981 CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT 10/31/2008
K170792 Cardiovascular Systems, Inc. Diamondback 360 Peripheral Orbital Atherectomy System 06/09/2017
K150732 CARDIOVASCULAR SYSTEMS, INC. Diamondback 360 Peripheral Orbital Atherectomy System 04/13/2015
K133999 CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM 02/28/2014
K111388 CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM 07/26/2011
K072748 CARDIOVASCULAR SYSTEMS, INC. MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM 11/09/2007
K110389 CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL PAD SYSTEM 03/11/2011
K122987 CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL PAD SYSTEM 10/25/2012
K141801 COVIDIEN, LLC HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM 10/16/2014
K920707 DEVICES FOR VASCULAR INTERVENTION, INC. HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER 11/23/1992
K935929 DEVICES FOR VASCULAR INTERVENTION, INC. MICROTRACK 03/10/1994
K904680 DOW CORNING WRIGHT THERATEK GROUP EXCHANGE CATHETER 12/27/1990
K915238 DOW CORNING WRIGHT TRAC-WRIGHT TRAC 10 CATHETER 02/19/1992
K021096 EV3 CORPORATION X-SIZER CATHETER SYSTEM 09/08/2004
K093301 EV3 INC TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM 11/06/2009
K111723 EV3 INC TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM 10/27/2011
K103618 EV3 INC TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM 01/05/2011
K181642 Eximo Medical Ltd. B-Laser Atherectomy System 10/05/2018
K053460 FOX HOLLOW TECHNOLOGIES MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, 01/13/2006
K024243 FOX HOLLOW TECHNOLOGIES REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 06/20/2003
K043553 FOX HOLLOW TECHNOLOGIES SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 02/18/2005
K071432 FOX HOLLOW TECHNOLOGIES SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE 02/12/2008
K061063 FOXHOLLOW TECHNOLOGIES, INC. MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 05/18/2006
K061188 FOXHOLLOW TECHNOLOGIES, INC. SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM 10/23/2006
K970233 GARY A. GELBFISH GELBFISH ENDO-VAC SYSTEM 10/08/1997
K924712 HEARING TECH, INC. ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM 12/08/1992
K953997 HEART TECHNOLOGY MFG., INC. ROTABLATOR ROTATIONAL ANGIOPLASTY 12/22/1995
K954604 HEART TECHNOLOGY MFG., INC. ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY 01/18/1996
K960379 HEART TECHNOLOGY MFG., INC. ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE 04/25/1996
K913450 HEART TECHNOLOGY, INC. HEART TECHNOLOGY ROTABLATOR WIRECLIP 09/06/1991
K901206 HEART TECHNOLOGY, INC. ROTABLATOR 09/14/1990
K933238 HEART TECHNOLOGY, INC. ROTABLATOR, MODIFICATION 08/24/1993
K030504 IDEV TECHNOLOGIES, INC. AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 09/16/2003
K922970 INTENSIVE TECHNOLOGY, INC. INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM 01/13/1993
K942457 INTRAMED LABORATORIES, INC. GRAFT THROMBECTOMY INSTRUMENTS 02/07/1995
K060016 KENSEY NASH CORP. THROMCAT THROMBECTOMY CATHETER SYSTEM 04/25/2006
K072195 KENSEY NASH CORP. THROMCAT THROMBECTOMY CATHETER SYSTEM 08/23/2007
K122916 MEDRAD, INC. JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM 10/19/2012
K133023 MEDRAD, INC. JETSTREAM SYSTEM 08/27/2014
K130637 MEDRAD, INC. JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM 04/10/2013
K161361 Medtronic Vascular, Inc. HawkOne Directional Atherectomy System 10/14/2016
K170191 MEDTRONIC VASCULAR, INC. SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System 06/16/2017
K963925 MICRO THERAPEUTICS, INC. THROMBOLYTIC BRUSH CATHETER 08/08/1997
K973669 MICRO THERAPEUTICS, INC. THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) 02/06/1998
K982657 MICROVENA CORP. AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 11/18/1998
K971984 MICROVENA CORP. AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) 09/19/1997
K954205 MICROVENA CORP. THE AMPLATZ THROMBECTOMY DEVICE 08/13/1996
K091509 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G2 NXT SYSTEM, MODEL PV20300 06/19/2009
K083837 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) 01/13/2009
K090325 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) 03/11/2009
K111229 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G3 (R) SF 1.6 SYSTEM 06/01/2011
K093918 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) 01/21/2010
K100462 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 05/19/2010
K101334 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON 06/11/2010
K093456 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G3 SYSTEM 12/01/2009
K092332 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) 09/03/2009
K101221 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 06/02/2010
K120242 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM NAVITUS L SYSTEM 02/24/2012
K110626 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM 04/20/2011
K083489 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 01/23/2009
K082664 PATHWAY MEDICAL TECHNOLOGIES, INC. JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 10/06/2008
K082186 PATHWAY MEDICAL TECHNOLOGIES, INC. MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM 08/29/2008
K081328 PATHWAY MEDICAL TECHNOLOGIES, INC. PATHWAY PV ATHERECTOMY SYSTEM 07/17/2008
K960970 POSSIS MEDICAL, INC. POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P 12/03/1996
K993564 POSSIS MEDICAL, INC. POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 04/28/2000
K033793 REX MEDICAL CLEANER II ROTATIONAL THROMBECTOMY SYSTEM 12/16/2003
K120346 REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM 06/01/2012
K091029 REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) 02/18/2010
K040252 REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT 02/26/2004
K031610 REX MEDICAL REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM 05/27/2003
K060904 REX MEDICAL LP CLEANER ROTATIONAL THROMBECTOMY SYSTEM 04/28/2006
K123632 SPECTRANETICS CORP. 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 01/25/2013
K094036 SPECTRANETICS CORP. TURBO-TANDEM SYSTEM MODEL 472-110 01/25/2010
K140775 SPECTRANETICS CORPORATION TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM 07/23/2014
K170059 Spectranetics, Inc. Spectranetics Turbo-Elite Laser Atherectomy Catheters 04/07/2017
K162561 SPECTRANETICS, INC. Turbo-Power (2.0mm) Laser Atherectomy Catheters 01/05/2017
K172687 Spectranetics, Inc. Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters 11/27/2017
K180694 Spectranetics, Inc. Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters 04/05/2018
K152181 SPECTRANETICS, INC. Turbo-Power Laser Atherectomy Catheter 11/12/2015
K172315 Straub Medical AG Rotarex S Catheter Set û 6F x 110 cm, Rotarex S Catheter Set û 6F x 135 cm, Rotarex S Catheter Set û 8F x 85 cm, Rotarex S Catheter Set û 8F x 110 cm, Drive System, Replacement Control Unit (with cord), Replacement Motor (with cord), Replacement Footswit 04/12/2018
K172386 Volcano AtheroMed Inc 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System 08/24/2017
K181877 Volcano AtheroMed Inc. Phoenix 2.4mm Atherectomy Plus System 12/17/2018
K182972 Volcano AtheroMed Inc. Phoenix Atherectomy System 12/20/2018
K143328 Volcano AtheroMed, Inc. 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip 12/19/2014
K151145 Volcano AtheroMed, Inc. 2.4mm X 127 cm Phoenix Atherectomy Deflecting System 05/26/2015
K013473 XTRAK MEDICAL INC. XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL 03/06/2002


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