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 |
K230005 |
Avinger, Inc. |
Pantheris LV Atherectomy Catheter |
06/06/2023 |
K182341 |
Avinger, Inc. |
Pantheris SV |
04/09/2019 |
K152275 |
Avinger, Inc. |
Pantheris System |
10/14/2015 |
K173862 |
Avinger, Inc. |
Pantheris System |
05/22/2018 |
K212047 |
Avinger, Inc. |
Pantheris System |
11/16/2021 |
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 |
K220962 |
Boston Scientific Corporation |
ROTAPRO Rotational Atherectomy System |
09/06/2022 |
K993648 |
BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER |
11/24/1999 |
K211738 |
C.R. Bard, Inc. |
Rotarex Atherectomy System |
09/14/2021 |
K231538 |
Cardio Flow, Inc. |
FreedomFlow Orbital Circumferential Atherectomy System |
09/27/2023 |
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 |
K220568 |
Cardiovascualr Systems Inc. |
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series |
04/27/2022 |
K151260 |
Cardiovascular System, Inc. |
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD |
06/10/2015 |
K210586 |
Cardiovascular Systems Inc. |
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system |
09/14/2021 |
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 |
K203008 |
Cardiovascular Systems Inc. |
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System |
11/19/2020 |
K220109 |
Cardiovascular Systems Inc. |
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System |
03/01/2022 |
K190634 |
Cardiovascular Systems Inc. |
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System |
07/02/2019 |
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 |
K133999 |
CARDIOVASCULAR SYSTEMS, INC. |
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
02/28/2014 |
K150732 |
CARDIOVASCULAR SYSTEMS, INC. |
Diamondback 360 Peripheral Orbital Atherectomy System |
04/13/2015 |
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 |
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 |
K220116 |
Eximo Medical Ltd. |
Auryon Atherectomy Catheters |
09/26/2022 |
K202835 |
Eximo Medical Ltd. |
Auryon Atherectomy System |
12/02/2020 |
K221077 |
Eximo Medical Ltd. |
Auryon Atherectomy System |
06/09/2022 |
K230709 |
Eximo Medical Ltd. |
Auryon Atherectomy System |
06/09/2023 |
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 |
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 |
K030504 |
IDEV TECHNOLOGIES, INC. |
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 |
09/16/2003 |
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 |
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 |
K133023 |
MEDRAD, INC. |
JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 |
08/27/2014 |
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 |
K212027 |
Medtronic, Inc |
TurboHawk Plus Directional Atherectomy System |
08/24/2021 |
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 |
K212351 |
Rex Medical, L.P. |
Revolution Peripheral Atherectomy System |
12/15/2021 |
K191419 |
Rex Medical, L.P. |
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire |
09/12/2019 |
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 |
K222837 |
Spectranetics Inc. |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
12/08/2022 |
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 |
Straub Endovascular System |
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 |
K211518 |
Volcano AtheroMed, Inc. |
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System |
06/14/2021 |
K013473 |
XTRAK MEDICAL INC. |
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL |
03/06/2002 |