FDA 510(k) Applications for Medical Device Product Code "DXE"
(Catheter, Embolectomy)

FDA 510(k) Number Applicant Device Name Decision Date
K972572 AMERICAN BIOMED, INC. SINGLE LUMEN EMBOLECTOMY CATHETER 01/13/1998
K864330 AMERICAN EDWARDS LABORATORIES SHEAR FORCE GAUGE 01/06/1987
K971314 ANGIODYNAMICS, INC. DCAT EMBOLECTOMY CATHETER SYSTEM 03/17/1998
K950586 APPLIED MEDICAL RESOURCES AVD INTIMAX THROMBECTOMY CATHETER 05/15/1995
K970762 APPLIED MEDICAL RESOURCES DUAL LUMEN EMBOLECTOMY CATHETER 03/28/1997
K973465 APPLIED MEDICAL RESOURCES LATIS GRAFT CLEANING CATHETER 02/19/1998
K901627 APPLIED VASCULAR DEVICES, INC. ARTERIAL EMBOLECTOMY CATHETER 10/19/1990
K910372 APPLIED VASCULAR DEVICES, INC. INTIMAX THROMBECTOMY CATHETER 04/26/1991
K982141 ARROW INTL., INC. ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 08/31/1998
K011056 ARROW INTL., INC. ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD 10/24/2001
K083370 ARTEGRAFT, INC. D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 12/12/2008
K820646 ATRIUM MEDICAL CORP. ATRAC TM MULTIPURPOSE BALLOON CATHETER 03/25/1982
K002627 ATRIUM MEDICAL CORP. ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER 04/26/2001
K020634 ATRIUM MEDICAL CORP. MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER 05/08/2002
K901625 BAXTER HEALTHCARE CORP. FOGARTY ARTERIAL EMBOLECTOMY II CATHETER 07/06/1990
K892410 BAXTER HEALTHCARE CORP. FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER 07/20/1989
K832023 BIONOMY, INC. EMBOLECTOMY CATHETER 08/31/1983
K051880 BOSTON SCIENTIFIC CORP. RIO ASPIRATION CATHETER 01/04/2006
K151313 BOSTON SCIENTIFIC CORPORATION ZelanteDVT Thrombectomy Set 09/21/2015
K171493 Capture Vascular, Inc. MegaVac Mechanical Thrombectomy System 08/10/2017
K897184 CATHLAB CORP. 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS 03/14/1990
K905139 CATHLAB CORP. CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER 02/25/1991
K881455 CATHLAB CORP. EMBOLECTOMY CATHETER(MODIFIED) 06/15/1988
K893680 CATHLAB CORP. SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. 08/01/1989
K902327 CLINCAL INSTRUMENTS CORP. EMBOLECTOMY CATHETER 02/25/1991
K132281 Codman & Shurtleff, Inc. REVASC THROMBECTOMY DEVICE 08/30/2013
K091703 CONCENTRIC MEDICAL, INC. HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 10/14/2009
K113757 CONTROL MEDICAL TECHNOLOGY, LLC ASPIRE MAX ASPIRATION CATHETER 02/22/2012
K131998 CONTROL MEDICAL TECHNOLOGY, LLC ASPIRE RX-LP6 ASPIRATION CATHETER 11/26/2013
K163031 COOK INCORPORATED Bunegin-Albin Air Aspiration Set 07/27/2017
K163353 Cook Incorporated Needle's Eye Snare Retrieval Set - 54cm 07/11/2017
K961992 COOK PACEMAKER CORP. NEEDLE'S EYE SNARE 12/27/1996
K073627 COOK, INC. FLEXOR EVAC ASPIRATION CATHETER 03/04/2008
K920823 COOK, INC. WELTER SNARE RETRIEVER 03/04/1993
K990771 CORDIS CORP. 6F HYDROLYSER THROMBECTOMY CATHETER 06/25/1999
K983534 CORDIS CORP. 7F HYDROLYSER THROMBECTOMY CATHETER 02/26/1999
K990805 CORDIS CORP. MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER 03/15/1999
K801650 DESERET MEDICAL, INC. DESERET EMBOLECTOMY/THROMBECTOMY CATH. 08/04/1980
K761031 ELECTRO-CATHETER CORP. ELECATH ARTERIAL EMBOLECTOMY CATHETER 12/13/1976
K780244 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. CATHETERS, ARTERIAL EMBOLECTOMY 04/13/1978
K071826 FOX HOLLOW TECHNOLOGIES THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 11/09/2007
K092623 GENESIS MEDICAL INTERVENTIONAL, INC. F.A.S.T. SYSTEM SED AND CXD 10/30/2009
K040010 GENESIS MEDICAL INTERVENTIONAL, INC. GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS 07/19/2004
K100840 HOTSPUR TECHNOLOGIES EMBO PLUS EMBOLECTOMY CATHETER 07/12/2010
K100842 HOTSPUR TECHNOLOGIES PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM 07/12/2010
K914880 IDEAL MEDICAL, INC. DUAL BALLOON EMBOLECTOMY CATHETER 03/16/1992
K891021 IDEAL MEDICAL, INC. TRI-LUMEN INTRA VASCULAR BALLOON CATHETER 09/18/1989
K872485 IDEAS FOR MEDICINE, INC. CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) 08/12/1987
K864062 IDEAS FOR MEDICINE, INC. PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED) 01/06/1987
K961716 IDEAS FOR MEDICINE, INC. VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE 09/19/1996
K961883 IDEAS FOR MEDICINE, INC. VERSA-CATH ARTERIAL CATHETER 01/13/1997
K041374 IDEV TECHNOLOGIES, INC. AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 03/02/2005
K900311 IMPRA, INC. ARTERIAL EMBOLECTOMY CATHETER 07/17/1990
K181694 Inari Medical Apiration Guide Catheter, Retraction Aspirator, FlowTriever Catheter 07/27/2018
K181325 Inari Medical Aspiration Guide Catheter; Retraction Aspirator 06/17/2018
K180329 Inari Medical ClotTriever Thrombectomy System 04/09/2018
K173470 Inari Medical ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath 12/04/2017
K180466 Inari Medical FlowTriever Catheter, 6-10 mm; FlowTreiver Catheter, 11-14 mm; FlowTreiver Catheter, 15-18 mm; Aspiration Guide Catheter; Retraction Aspirator 05/17/2018
K173672 Inari Medical FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter 02/05/2018
K162970 Inari Medical FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator 11/22/2016
K152097 INARI MEDICAL Retraction Aspirator 08/25/2015
K163549 Inari Medical, Inc. ClotTriever Thrombectomy System 02/16/2017
K143563 Inari Medical, Inc. Infusion Aspiration Catheter System 02/03/2015
K050276 INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. DIVER C.E. CATHETER 03/07/2005
K051917 INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. DIVER C.E. CATHETER 08/08/2005
K935405 J-LLOYD MEDICAL, INC. ARTERIAL EMBOLECTOMY 07/25/1994
K974335 J-LLOYD MEDICAL, INC. EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. 02/13/1998
K920871 J-LLOYD MEDICAL, INC. J-LLOYD ARTERIAL EMBOLECTOMY CATHETER 02/26/1993
K101839 KANEKA PHARMA AMERICA LLC KANEKA PHARMA AMERICA XPRESS-WAY RX 10/22/2010
K121301 KANEKA PHARMA AMERICA LLC XPRESSWAY RX CATHETER (6F LD-VERISON) 07/30/2012
K060092 KENSEY NASH CORP. QUICKCAT EXTRACTION CATHETER 03/09/2006
K073519 KENSEY NASH CORP. QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 03/28/2008
K050130 KERBEROS PROXIMAL SOLUTIONS, INC. KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM 05/13/2005
K062275 KERBEROS PROXIMAL SOLUTIONS, INC. RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 09/20/2006
K180722 KP Medcure, Inc. CAPERE Thrombectomy System 06/11/2018
K022145 LEMAITRE VASCULAR, INC. OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 01/14/2003
K954760 LUCAS MEDICAL, INC. LMI ARTERIAL EMBOLECTOMY CATHETER 04/11/1996
K972623 LUCAS MEDICAL, INC. LMI IRRIGATION CATHETER (IGR) 11/19/1997
K955125 LUCAS MEDICAL, INC. LMI OCCLUSION CATHETER 03/11/1996
K970657 LUCAS MEDICAL, INC. LMI THROMBECTOMY CATHETER 07/01/1997
K053372 LUMEN BIOMEDICAL, INC. LBI CATHETER SYSTEM 06/30/2006
K080901 LUMEN BIOMEDICAL, INC. LBI EMBOLECTOMY SYSTEM 10/02/2008
K071529 LUMEN BIOMEDICAL, INC. XTRACT CATHETER SYSTEM 08/10/2007
K770714 MALLINCKRODT CRITICAL CARE CATHETER, ARTERIAL EMBOLECTOMY 04/27/1977
K101406 MEDRAD INTERVENTIONAL/POSSIS ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 06/16/2010
K101354 MEDRAD INTERVENTIONAL/POSSIS FETCH 2 ASPIRATION CATHETER MODEL 109400-001 01/21/2011
K113363 MEDRAD, INC. ANGIOJET SOLENT DISTA THROMBECTOMY SET 06/06/2012
K111182 MEDRAD, INC. ANGIOJET SOLENT OMNI THROMBECTOMY SET 05/24/2011
K113428 MEDRAD, INC. ANGIOJET ULTRA DVX THROMBECTOMY SET 12/02/2011
K130536 MEDTRONIC INC. EXPORT ADVANCE ASPIRATION CATHETER 07/16/2013
K120808 MEDTRONIC INC. EXPORT XT CATHETER, EXPORT AP CATHETER 06/07/2012
K040869 MEDTRONIC VASCULAR EXPORT CATHETER 06/01/2004
K081573 MEDTRONIC VASCULAR MEDTRONIC EXPORT AP CATHETER 06/27/2008
K061958 MEDTRONIC VASCULAR MEDTRONIC EXPORT XT CATHETER 09/05/2006
K050139 MEDTRONIC VASCULAR MODIFICATION TO: EXPORT CATHETER 03/22/2005
K152335 Medtronic, Inc. Export Advance Aspiration Catheter 09/18/2015
K132155 MERIT MEDICAL SYSTEMS, INC. ASAPLP ASPIRATION CATHETER 11/07/2013
K100569 MERIT MEDICAL SYSTEMS, INC. MERIT EMBOLECTOMY CATHETER MODEL ASAP100 03/11/2011
K991093 METAMORPHIC SURGICAL DEVICES, LLC. MSD EMBOLECTOMY BASKET 12/21/2000
K901502 MICROVENA CORP. AMPLATZ "GOOSE-NECK" SNARE 12/03/1990
K972511 MICROVENA CORP. AMPLATZ GOOSE NECK SNARE KIT/ CATHETER 03/06/1998
K110315 NEXGEN MEDICAL SYSTEMS, INC. NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE 10/20/2011
K090932 NEXGEN MEDICAL SYSTEMS, INC. NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 09/24/2009
K853625 NOVA MEDICAL SPECIALTIES NOVA ARTERIAL EMBOLECTOMY CATHETER 01/15/1986
K052428 OMNISONICS MEDICAL TECHNOLOGIES RESOLUTION ENDOVASCULAR SYSTEM 12/08/2005
K041705 OMNISONICS MEDICAL TECHNOLOGIES RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 09/01/2004
K161523 Penumbra, Inc. INDIGO Aspiration System 07/01/2016
K163618 PENUMBRA, INC. INDIGO Aspiration System 05/24/2017
K180412 Penumbra, Inc. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump Canister 05/15/2018
K180939 Penumbra, Inc. Indigo Aspiration System - Modified 110 Aspiration Tubing 05/03/2018
K180105 Penumbra, Inc. Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister 03/08/2018
K161506 Penumbra, Inc. Penumbra Aspiration System 09/26/2016
K121917 PENUMBRA, INC. PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM 09/19/2012
K160533 PENUMBRA, INC. Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) 05/24/2016
K142870 PENUMBRA, INC. Penumbra Embolectomy Aspiration System [INDIGO System] 05/26/2015
K011783 PFM PRODUKTE FUR DIE MEDIZIN AG MULTI-SNARE SET 01/24/2002
K850015 POLYMED LABORATORIES POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER 06/19/1985
K091593 POSSIS MEDICAL, INC. ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS 06/22/2009
K050794 POSSIS MEDICAL, INC. ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER 04/28/2005
K133629 POSSIS MEDICAL, INC. ANGIOJET ULTRA AVX THROMBECTOMY SET 02/14/2014
K073441 POSSIS MEDICAL, INC. ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 01/24/2008
K082382 POSSIS MEDICAL, INC. ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 12/12/2008
K090253 POSSIS MEDICAL, INC. ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 04/08/2009
K072269 POSSIS MEDICAL, INC. ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 09/08/2007
K080806 POSSIS MEDICAL, INC. ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 04/04/2008
K071342 POSSIS MEDICAL, INC. ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 07/31/2007
K072769 POSSIS MEDICAL, INC. ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS 11/14/2007
K042874 POSSIS MEDICAL, INC. ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) 11/05/2004
K052256 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR 120 CATHETER 11/10/2005
K040013 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT 05/18/2004
K071336 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 08/24/2007
K071514 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 07/31/2007
K061951 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 11/22/2006
K062172 POSSIS MEDICAL, INC. FETCH ASPIRATION CATHETER 09/20/2006
K070363 POSSIS MEDICAL, INC. FETCH ASPIRATION CATHETER 05/11/2007
K081989 POSSIS MEDICAL, INC. MODIFICATION TO FETCH ASPIRATION CATHETER 09/26/2008
K972610 POSSIS MEDICAL, INC. POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C 04/11/2000
K840198 SHILEY, INC. ARTERIAL EMBOLECTOMY CATHETER 08/03/1984
K790838 SHILEY, INC. ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) 06/11/1979
K780762 SHILEY, INC. EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE 05/26/1978
K894681 SHILEY, INC. REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER 10/12/1989
K832044 SHILEY, INC. SHILEY MULTIPRO CATHETER 09/29/1983
K973477 SUNSCOPE INTL., INC. BIOSENSORS EMBOLECTOMY CATHETER 09/04/1998
K112382 Terumo Medical Corporation TERUMO ASPRIATION CATHETER 12/14/2011
K770569 UNIVERSAL MEDICAL INSTRUMENT CORP. CATHETER, EMBOLECTOMY, UMI 04/05/1977
K864007 URESIL CORP. EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER 01/02/1987
K812640 URESIL CORP. URE SIL EMBOLECTOMY/THROMBECTOMY CATH 10/02/1981
K172716 V2K Medical Inc. V2K Rinspiration System, P7 Catheter - 9mm Rinse x 135cm Working Length, V2K Rinspiration System, P7 Catheter - 20mm Rinse x 135cm Working Length, V2K Rinspiration System, Filter Line - 108 Length 01/26/2018
K173266 Vascular Solutions Inc. Octane aspiration system 12/01/2017
K042937 VASCULAR SOLUTIONS, INC. MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER 01/31/2005
K070403 VASCULAR SOLUTIONS, INC. PRONTO .035 EXTRACTION CATHETER 06/13/2007
K072810 VASCULAR SOLUTIONS, INC. PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 12/19/2007
K063371 VASCULAR SOLUTIONS, INC. PRONTO V3 EXTRACTION CATHETER, MODEL 5003 12/14/2006
K083784 VASCULAR SOLUTIONS, INC. PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, 03/30/2009
K103405 VASCULAR SOLUTIONS, INC. PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH 12/22/2010
K071727 VASCULAR SOLUTIONS, INC. QXT EXTRACTION CATHETER 09/28/2007
K032763 VASCULAR SOLUTIONS, INC. VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER 12/19/2003
K051193 VASCULAR SOLUTIONS, INC. VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER 08/08/2005
K052232 VASCULAR SOLUTIONS, INC. VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER 09/28/2005
K112571 VASCULAR SOLUTIONS, INC. XL EXTRACTION CATHETER 10/06/2011
K992940 VASCUTECH, INC. LEMAITRE BALLOON CATHETER WITH IRRIGATION 02/22/2000
K992368 VASCUTECH, INC. LEMAITRE EMBOLECTOMY CATHETER 12/09/1999
K992933 VASCUTECH, INC. LEMAITRE IRRIGATION CATHETER 03/08/2000
K992934 VASCUTECH, INC. LEMAITRE VENOUS THROMBECTOMY CATHETER 03/01/2000
K123482 VOLCANO CORPORATION REFLOW ASPIRATION CATHETER 04/29/2013
K120508 WALK VASCULAR LLC CLEARLUMEN THROMBECTOMY SYSTEM 11/07/2012
K163051 Walk Vascular, LLC ClearLumen II Peripheral Thrombectomy System 02/21/2017
K172000 Walk Vascular, LLC ClearLumen II Peripheral Thrombectomy System 10/24/2017
K161786 Walk Vascular, LLC ClearLumen II Thrombectomy System 10/18/2016
K140296 WALK VASCULAR, LLC CLEARLUMEN THROMBECTOMY SYSTEM 12/02/2014
K883852 WB INTL., INC. CATHETER, CARDIOVASCULAR, BALLOON TYPE 12/07/1989
K021641 XTRAK MEDICAL INC. XTD THROMBECTOMY CATHETER, XX CM 07/26/2002


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