FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K213388 |
AngioDynamics, Inc. |
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System |
04/04/2022 |
K211081 |
AngioDynamics, Inc. |
AlphaVac Multipurpose Mechanical Aspiration (MMA) System |
06/04/2021 |
K051880 |
BOSTON SCIENTIFIC CORP. |
RIO ASPIRATION CATHETER |
01/04/2006 |
K091703 |
CONCENTRIC MEDICAL, INC. |
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 |
10/14/2009 |
K200871 |
Control Medical Technology |
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator |
05/04/2020 |
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 |
K073627 |
COOK, INC. |
FLEXOR EVAC ASPIRATION CATHETER |
03/04/2008 |
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 |
K071826 |
FOX HOLLOW TECHNOLOGIES |
THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 |
11/09/2007 |
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 |
K213166 |
Kaneka Medical America LLC |
Thrombuster II Aspiration Catheter |
10/26/2021 |
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 |
K053372 |
LUMEN BIOMEDICAL, INC. |
LBI CATHETER SYSTEM |
06/30/2006 |
K071529 |
LUMEN BIOMEDICAL, INC. |
XTRACT CATHETER SYSTEM |
08/10/2007 |
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 |
K061958 |
MEDTRONIC VASCULAR |
MEDTRONIC EXPORT XT CATHETER |
09/05/2006 |
K050139 |
MEDTRONIC VASCULAR |
MODIFICATION TO: EXPORT CATHETER |
03/22/2005 |
K190619 |
Meril Life Sciences Private Limited |
Aspiron(TM) Aspiration Catheter |
04/29/2019 |
K212199 |
Merit Medical Systems, Inc. |
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter |
11/03/2021 |
K132155 |
MERIT MEDICAL SYSTEMS, INC. |
Merit ASAPLP Aspiration Catheter |
11/07/2013 |
K100569 |
MERIT MEDICAL SYSTEMS, INC. |
MERIT EMBOLECTOMY CATHETER MODEL ASAP100 |
03/11/2011 |
K110315 |
NEXGEN MEDICAL SYSTEMS, INC. |
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE |
10/20/2011 |
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 |
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 |
K112382 |
Terumo Medical Corporation |
TERUMO ASPRIATION CATHETER |
12/14/2011 |
K173266 |
Vascular Solutions Inc. |
Octane aspiration system |
12/01/2017 |
K042937 |
VASCULAR SOLUTIONS, INC. |
MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER |
01/31/2005 |
K182232 |
Vascular Solutions, Inc. |
Octane Mechanical Thrombectomy System |
09/11/2018 |
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 |
K193197 |
Volcano AtheroMed Inc. |
QuickClear Mechanical Thrombectomy System |
04/20/2020 |
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 |
K183403 |
Walk Vascular, LLC |
JETi 88 Peripheral Thrombectomy System |
04/17/2019 |
K201998 |
Walk Vascular, LLC |
JETi AIO Peripheral Thrombectomy System |
11/17/2020 |
K213565 |
Walk Vascular, LLC |
JETi AIO Peripheral Thrombectomy System |
02/01/2022 |
K192439 |
Walk Vascular, LLC |
JETi Peripheral Thrombectomy System |
12/09/2019 |