FDA Product Code
FDA Product Code QEW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5150
510(k) Clearances — 145 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192935 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2019-11-15 | Special | PDF ↗ |
| K192332 | ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath | Inari Medical | 2019-09-20 | Special | PDF ↗ |
| K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019-09-05 | Traditional | PDF ↗ |
| K192036 | ClotTriever Thrombectomy System | Inari Medical | 2019-08-29 | Special | PDF ↗ |
| K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019-06-17 | Special | PDF ↗ |
| K182835 | WOLF Thrombectomy Device | 880 Medical, LLC | 2019-03-27 | Traditional | PDF ↗ |
| K183179 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2019-02-25 | Traditional | PDF ↗ |
| K182167 | The ICHOR Panacea Vascular Embolectomy Catheter System | Ichor Vascular, Inc. | 2018-12-21 | Traditional | PDF ↗ |
| K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018-12-17 | Special | PDF ↗ |
| K182233 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018-10-15 | Traditional | PDF ↗ |
| K182531 | ClotTriever Thrombectomy System | Inari Medical | 2018-10-10 | Special | PDF ↗ |
| K181694 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018-07-27 | Special | PDF ↗ |
| K181325 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | 2018-06-17 | Special | PDF ↗ |
| K180722 | CAPERE Thrombectomy System | Kp Medcure, Inc. | 2018-06-11 | Traditional | PDF ↗ |
| K180466 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | 2018-05-17 | Traditional | PDF ↗ |
| K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister | Penumbra, Inc. | 2018-05-15 | Traditional | PDF ↗ |
| K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. | 2018-05-03 | Special | PDF ↗ |
| K180329 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2018-04-09 | Special | PDF ↗ |
| K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister | Penumbra, Inc. | 2018-03-08 | Special | PDF ↗ |
| K173672 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter | Inari Medical | 2018-02-05 | Special | PDF ↗ |
| K172716 | V2K Rinspiration System | V2k Medical, Inc. | 2018-01-26 | Traditional | PDF ↗ |
| K173470 | ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath | Inari Medical | 2017-12-04 | Special | PDF ↗ |
| K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2017-02-16 | Traditional | PDF ↗ |
| K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator | Inari Medical | 2016-11-22 | Special | PDF ↗ |
| K161506 | Penumbra Aspiration System | Penumbra, Inc. | 2016-09-26 | Traditional | PDF ↗ |
| K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016-07-01 | Special | PDF ↗ |
| K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016-05-24 | Traditional | PDF ↗ |
| K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015-09-21 | Traditional | PDF ↗ |
| K152097 | Retraction Aspirator | Inari Medical | 2015-08-25 | Special | PDF ↗ |
| K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015-05-26 | Traditional | PDF ↗ |
| K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015-02-03 | Traditional | PDF ↗ |
| K141617 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | Rex Medical, L.P. | 2014-11-14 | Traditional | PDF ↗ |
| K133629 | ANGIOJET ULTRA AVX THROMBECTOMY SET | Possis Medical, Inc. | 2014-02-14 | Special | PDF ↗ |
| K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | Codman & Shurtleff, Inc. | 2013-08-30 | Special | PDF ↗ |
| K130381 | ANGIOJET ULTRA POWER PULSE KIT | Medrad, Inc. | 2013-07-29 | Traditional | PDF ↗ |
| K121917 | PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM | Penumbra, Inc. | 2012-09-19 | Traditional | PDF ↗ |
| K092623 | F.A.S.T. SYSTEM SED AND CXD | Genesis Medical Interventional, Inc. | 2009-10-30 | Special | PDF ↗ |
| K090932 | NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 | Nexgen Medical Systems, Inc. | 2009-09-24 | Traditional | PDF ↗ |
| K083370 | D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 | Artegraft, Inc. | 2008-12-12 | Special | PDF ↗ |
| K080901 | LBI EMBOLECTOMY SYSTEM | Lumen Biomedical, Inc. | 2008-10-02 | Traditional | PDF ↗ |
| K041374 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 | Idev Technologies, Inc. | 2005-03-02 | Traditional | PDF ↗ |
| K040010 | GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS | Genesis Medical Interventional, Inc. | 2004-07-19 | Traditional | PDF ↗ |
| K021641 | XTD THROMBECTOMY CATHETER, XX CM | Xtrak Medical, Inc. | 2002-07-26 | Special | PDF ↗ |
| K011056 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD | Arrow Intl., Inc. | 2001-10-24 | Traditional | PDF ↗ |
| K991093 | MSD EMBOLECTOMY BASKET | Metamorphic Surgical Devices, LLC | 2000-12-21 | Traditional | PDF ↗ |
Product code QEW · Class II · Cardiovascular. Data: openFDA.