FDA Product Code
FDA Product Code QEZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5150
510(k) Clearances — 95 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254035 | Mayumi Thrombectomy System | MicroVention, Inc., d/b/a Terumo Neuro | 2026-09-03 | Traditional | PDF ↗ |
| K261105 | Powered Aventus Thrombectomy System | Inquis Medical | 2026-07-27 | Traditional | PDF ↗ |
| K262030 | Aventus Thrombectomy System | Inquis Medical | 2026-07-15 | Special | PDF ↗ |
| K253589 | Liberant RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | 2026-04-23 | Traditional | PDF ↗ |
| K254208 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | 2026-03-20 | Special | PDF ↗ |
| K253925 | Aventus Thrombectomy System | Inquis Medical | 2026-01-15 | Traditional | PDF ↗ |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | 2025-11-24 | Traditional | PDF ↗ |
| K251312 | Vesalio Peripheral System | Vesalio, Inc. | 2025-10-24 | Traditional | PDF ↗ |
| K251488 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | 2025-07-14 | Special | PDF ↗ |
| K243549 | JETi Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | 2025-04-04 | Traditional | PDF ↗ |
| K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) | Control Medical Technology, Inc. / Dba Ventiv Scientific | 2025-03-24 | Special | PDF ↗ |
| K240397 | AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. | 2024-04-01 | Traditional | PDF ↗ |
| K232458 | JETiHydrodynamic Thrombectomy System | ABBOTT MEDICAL | 2023-12-19 | Traditional | PDF ↗ |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics, Inc. | 2022-04-04 | Traditional | PDF ↗ |
| K213565 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2022-02-01 | Traditional | PDF ↗ |
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2021-11-03 | Special | PDF ↗ |
| K213166 | Thrombuster II Aspiration Catheter | Kaneka Medical America, LLC | 2021-10-26 | Special | PDF ↗ |
| K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | AngioDynamics, Inc. | 2021-06-04 | Traditional | PDF ↗ |
| K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2020-11-17 | Traditional | PDF ↗ |
| K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator | Control Medical Technology | 2020-05-04 | Special | PDF ↗ |
| K193197 | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | 2020-04-20 | Traditional | PDF ↗ |
| K192439 | JETi Peripheral Thrombectomy System | Walk Vascular, LLC | 2019-12-09 | Traditional | PDF ↗ |
| K190619 | Aspiron(TM) Aspiration Catheter | Meril Life Sciences Private Limited | 2019-04-29 | Traditional | PDF ↗ |
| K183403 | JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC | 2019-04-17 | Traditional | PDF ↗ |
| K182232 | Octane Mechanical Thrombectomy System | Vascular Solutions, Inc. | 2018-09-11 | Special | PDF ↗ |
| K173266 | Octane aspiration system | Vascular Solutions, Inc. | 2017-12-01 | Traditional | PDF ↗ |
| K172000 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | 2017-10-24 | Traditional | PDF ↗ |
| K163051 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | 2017-02-21 | Traditional | PDF ↗ |
| K161786 | ClearLumen II Thrombectomy System | Walk Vascular, LLC | 2016-10-18 | Traditional | PDF ↗ |
| K140296 | CLEARLUMEN THROMBECTOMY SYSTEM | Walk Vascular, LLC | 2014-12-02 | Traditional | PDF ↗ |
| K131998 | ASPIRE RX-LP6 ASPIRATION CATHETER | Control Medical Technology, LLC | 2013-11-26 | Traditional | PDF ↗ |
| K132155 | Merit ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2013-11-07 | Traditional | PDF ↗ |
| K130536 | EXPORT ADVANCE ASPIRATION CATHETER | Medtronic, Inc. | 2013-07-16 | Traditional | PDF ↗ |
| K123482 | REFLOW ASPIRATION CATHETER | Volcano Corporation | 2013-04-29 | Traditional | PDF ↗ |
| K120508 | CLEARLUMEN THROMBECTOMY SYSTEM | Walk Vascular, LLC | 2012-11-07 | Traditional | PDF ↗ |
| K121301 | XPRESSWAY RX CATHETER (6F LD-VERISON) | Kaneka Pharma America, LLC | 2012-07-30 | Special | PDF ↗ |
| K120808 | EXPORT XT CATHETER, EXPORT AP CATHETER | Medtronic, Inc. | 2012-06-07 | Special | PDF ↗ |
| K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET | Medrad, Inc. | 2012-06-06 | Traditional | PDF ↗ |
| K113757 | ASPIRE MAX ASPIRATION CATHETER | Control Medical Technology, LLC | 2012-02-22 | Traditional | PDF ↗ |
| K112382 | TERUMO ASPRIATION CATHETER | Terumo Medical Corporation | 2011-12-14 | Traditional | PDF ↗ |
| K113428 | ANGIOJET ULTRA DVX THROMBECTOMY SET | Medrad, Inc. | 2011-12-02 | Special | PDF ↗ |
| K110315 | NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE | Nexgen Medical Systems, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K112571 | XL EXTRACTION CATHETER | Vascular Solutions, Inc. | 2011-10-06 | Special | PDF ↗ |
| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | Medrad, Inc. | 2011-05-24 | Special | PDF ↗ |
| K100569 | MERIT EMBOLECTOMY CATHETER MODEL ASAP100 | Merit Medical Systems, Inc. | 2011-03-11 | Traditional | PDF ↗ |
| K101354 | FETCH 2 ASPIRATION CATHETER MODEL 109400-001 | Medrad Interventional/Possis | 2011-01-21 | Traditional | PDF ↗ |
| K103405 | PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH | Vascular Solutions, Inc. | 2010-12-22 | Special | PDF ↗ |
| K101839 | KANEKA PHARMA AMERICA XPRESS-WAY RX | Kaneka Pharma America, LLC | 2010-10-22 | Traditional | PDF ↗ |
| K101406 | ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 | Medrad Interventional/Possis | 2010-06-16 | Special | PDF ↗ |
| K091703 | HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 | Concentric Medical, Inc. | 2009-10-14 | Traditional | PDF ↗ |
| K091593 | ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS | Possis Medical, Inc. | 2009-06-22 | Special | PDF ↗ |
| K090253 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 | Possis Medical, Inc. | 2009-04-08 | Traditional | PDF ↗ |
| K083784 | PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, | Vascular Solutions, Inc. | 2009-03-30 | Traditional | PDF ↗ |
| K082382 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 | Possis Medical, Inc. | 2008-12-12 | Traditional | PDF ↗ |
| K081989 | MODIFICATION TO FETCH ASPIRATION CATHETER | Possis Medical, Inc. | 2008-09-26 | Special | PDF ↗ |
| K080806 | ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 | Possis Medical, Inc. | 2008-04-04 | Traditional | PDF ↗ |
| K073519 | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 | Kensey Nash Corp. | 2008-03-28 | Special | PDF ↗ |
| K073627 | FLEXOR EVAC ASPIRATION CATHETER | Cook, Inc. | 2008-03-04 | Traditional | PDF ↗ |
| K073441 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 | Possis Medical, Inc. | 2008-01-24 | Traditional | PDF ↗ |
| K072810 | PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 | Vascular Solutions, Inc. | 2007-12-19 | Traditional | PDF ↗ |
| K072769 | ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS | Possis Medical, Inc. | 2007-11-14 | Traditional | PDF ↗ |
| K071826 | THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 | Fox Hollow Technologies | 2007-11-09 | Special | PDF ↗ |
| K071727 | QXT EXTRACTION CATHETER | Vascular Solutions, Inc. | 2007-09-28 | Traditional | PDF ↗ |
| K072269 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 | Possis Medical, Inc. | 2007-09-08 | Traditional | PDF ↗ |
| K071336 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 | Possis Medical, Inc. | 2007-08-24 | Traditional | PDF ↗ |
| K071529 | XTRACT CATHETER SYSTEM | Lumen Biomedical, Inc. | 2007-08-10 | Special | PDF ↗ |
| K071514 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 | Possis Medical, Inc. | 2007-07-31 | Traditional | PDF ↗ |
| K071342 | ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 | Possis Medical, Inc. | 2007-07-31 | Traditional | PDF ↗ |
| K070403 | PRONTO .035 EXTRACTION CATHETER | Vascular Solutions, Inc. | 2007-06-13 | Traditional | PDF ↗ |
| K070363 | FETCH ASPIRATION CATHETER | Possis Medical, Inc. | 2007-05-11 | Traditional | PDF ↗ |
| K063371 | PRONTO V3 EXTRACTION CATHETER, MODEL 5003 | Vascular Solutions, Inc. | 2006-12-14 | Traditional | PDF ↗ |
| K061951 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 | Possis Medical, Inc. | 2006-11-22 | Traditional | PDF ↗ |
| K062172 | FETCH ASPIRATION CATHETER | Possis Medical, Inc. | 2006-09-20 | Traditional | PDF ↗ |
| K062275 | RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 | Kerberos Proximal Solutions, Inc. | 2006-09-20 | Special | PDF ↗ |
| K061958 | MEDTRONIC EXPORT XT CATHETER | Medtronic Vascular | 2006-09-05 | Special | PDF ↗ |
| K053372 | LBI CATHETER SYSTEM | Lumen Biomedical, Inc. | 2006-06-30 | Traditional | PDF ↗ |
| K060092 | QUICKCAT EXTRACTION CATHETER | Kensey Nash Corp. | 2006-03-09 | Traditional | PDF ↗ |
| K051880 | RIO ASPIRATION CATHETER | Boston Scientific Corp | 2006-01-04 | Traditional | PDF ↗ |
| K052256 | ANGIOJET XPEEDIOR 120 CATHETER | Possis Medical, Inc. | 2005-11-10 | Traditional | PDF ↗ |
| K052232 | VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER | Vascular Solutions, Inc. | 2005-09-28 | Traditional | PDF ↗ |
| K051917 | DIVER C.E. CATHETER | Invatec Innovative Technologies, S.R.L. | 2005-08-08 | Traditional | PDF ↗ |
| K051193 | VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER | Vascular Solutions, Inc. | 2005-08-08 | Traditional | PDF ↗ |
| K050130 | KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM | Kerberos Proximal Solutions, Inc. | 2005-05-13 | Traditional | PDF ↗ |
| K050794 | ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER | Possis Medical, Inc. | 2005-04-28 | Special | PDF ↗ |
| K050139 | MODIFICATION TO: EXPORT CATHETER | Medtronic Vascular | 2005-03-22 | Special | PDF ↗ |
| K050276 | DIVER C.E. CATHETER | Invatec Innovative Technologies, S.R.L. | 2005-03-07 | Traditional | PDF ↗ |
| K042937 | MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER | Vascular Solutions, Inc. | 2005-01-31 | Special | PDF ↗ |
| K042874 | ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) | Possis Medical, Inc. | 2004-11-05 | Special | PDF ↗ |
| K040869 | EXPORT CATHETER | Medtronic Vascular | 2004-06-01 | Traditional | PDF ↗ |
| K040013 | ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT | Possis Medical, Inc. | 2004-05-18 | Traditional | PDF ↗ |
| K032763 | VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER | Vascular Solutions, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K972610 | POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C | Possis Medical, Inc. | 2000-04-11 | Traditional | PDF ↗ |
| K990771 | 6F HYDROLYSER THROMBECTOMY CATHETER | Cordis Corp. | 1999-06-25 | Traditional | PDF ↗ |
| K990805 | MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER | Cordis Corp. | 1999-03-15 | Special | PDF ↗ |
| K983534 | 7F HYDROLYSER THROMBECTOMY CATHETER | Cordis Corp. | 1999-02-26 | Traditional | PDF ↗ |
Product code QEZ · Class II · Cardiovascular. Data: openFDA.