Panels › Cardiovascular › Product code QEW · Class 2
Peripheral Mechanical Thrombectomy With Aspiration
Regulation 870.5150
12510(k)s in 12 months (146 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in QEW
| Company | 510(k)s | Recalls |
|---|---|---|
| Inari Medical | 49 | 0 |
| Penumbra, Inc. | 27 | 0 |
| TELEFLEX MEDICAL INC | 0 | 7 |
| Devoro Medical, Inc. | 5 | 0 |
| Inquis Medical | 5 | 0 |
| Surmodics,Inc. | 5 | 0 |
| Vascular Medcure, Inc. | 5 | 0 |
| Argon Medical Devices, Inc. | 4 | 0 |
| Contego Medical, Inc. | 4 | 0 |
| Endovascular Engineering | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2019 | K192833 | Indigo Aspiration System Penumbra, Inc. | QEW |
| Nov 15, 2019 | K192935 | CAPERE Thrombectomy System Vascular Medcure, Inc. | QEW |
| Sep 20, 2019 | K192332 | ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical | QEW |
| Sep 5, 2019 | K191710 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Aug 29, 2019 | K192036 | ClotTriever Thrombectomy System Inari Medical | QEW |
| Jun 17, 2019 | K191368 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Mar 27, 2019 | K182835 | WOLF Thrombectomy Device 880 Medical, LLC | QEW |
| Feb 25, 2019 | K183179 | CAPERE Thrombectomy System Vascular Medcure, Inc. | QEW |
| Dec 21, 2018 | K182167 | The ICHOR Panacea Vascular Embolectomy Catheter System Ichor Vascular, Inc. | QEW |
| Dec 17, 2018 | K183198 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Oct 15, 2018 | K182233 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Oct 10, 2018 | K182531 | ClotTriever Thrombectomy System Inari Medical | QEW |
| Jul 27, 2018 | K181694 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Jun 17, 2018 | K181325 | FlowTriever Retrieval/Aspiration System Inari Medical, Inc. | QEW |
| Jun 11, 2018 | K180722 | CAPERE Thrombectomy System Kp Medcure, Inc. | QEW |
| May 17, 2018 | K180466 | FlowTriever Retrieval/Aspiration System Inari Medical, Inc. | QEW |
| May 15, 2018 | K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister Penumbra, Inc. | QEW |
| May 3, 2018 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing Penumbra, Inc. | QEW |
| Apr 9, 2018 | K180329 | ClotTriever Thrombectomy System Inari Medical, Inc. | QEW |
| Mar 8, 2018 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister Penumbra, Inc. | QEW |
| Feb 5, 2018 | K173672 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter Inari Medical | QEW |
| Jan 26, 2018 | K172716 | V2K Rinspiration System V2k Medical, Inc. | QEW |
| Dec 4, 2017 | K173470 | ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical | QEW |
| Feb 16, 2017 | K163549 | ClotTriever Thrombectomy System Inari Medical, Inc. | QEW |
| Nov 22, 2016 | K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator Inari Medical | QEW |
| Sep 26, 2016 | K161506 | Penumbra Aspiration System Penumbra, Inc. | QEW |
| Jul 1, 2016 | K161523 | INDIGO Aspiration System Penumbra, Inc. | QEW |
| May 24, 2016 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) Penumbra, Inc. | QEW |
| Sep 21, 2015 | K151313 | ZelanteDVT Thrombectomy Set Boston Scientific Corporation | QEW |
| Aug 25, 2015 | K152097 | Retraction Aspirator Inari Medical | QEW |
| May 26, 2015 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] Penumbra, Inc. | QEW |
| Feb 3, 2015 | K143563 | Infusion Aspiration Catheter System Inari Medical, Inc. | QEW |
| Nov 14, 2014 | K141617 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical, L.P. | QEW |
| Feb 14, 2014 | K133629 | ANGIOJET ULTRA AVX THROMBECTOMY SET Possis Medical, Inc. | QEW |
| Aug 30, 2013 | K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device Codman & Shurtleff, Inc. | QEW |
| Jul 29, 2013 | K130381 | ANGIOJET ULTRA POWER PULSE KIT Medrad, Inc. | QEW |
| Sep 19, 2012 | K121917 | PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM Penumbra, Inc. | QEW |
| Oct 30, 2009 | K092623 | F.A.S.T. SYSTEM SED AND CXD Genesis Medical Interventional, Inc. | QEW |
| Sep 24, 2009 | K090932 | NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 Nexgen Medical Systems, Inc. | QEW |
| Dec 12, 2008 | K083370 | D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 Artegraft, Inc. | QEW |
| Oct 2, 2008 | K080901 | LBI EMBOLECTOMY SYSTEM Lumen Biomedical, Inc. | QEW |
| Mar 2, 2005 | K041374 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 Idev Technologies, Inc. | QEW |
| Jul 19, 2004 | K040010 | GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS Genesis Medical Interventional, Inc. | QEW |
| Jul 26, 2002 | K021641 | XTD THROMBECTOMY CATHETER, XX CM Xtrak Medical, Inc. | QEW |
| Oct 24, 2001 | K011056 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD Arrow Intl., Inc. | QEW |
| Dec 21, 2000 | K991093 | MSD EMBOLECTOMY BASKET Metamorphic Surgical Devices, LLC | QEW |
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