FDA 510(k) Applications for Medical Device Product Code "QEW"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220780 | 2MG, Inc | ROVO Mechanical Thrombectomy Device | 03/31/2023 |
| K182835 | 880 Medical, LLC | WOLF Thrombectomy Device | 03/27/2019 |
| K211798 | Argon Medical Devices, Inc. | Cleaner Plus Thrombectomy System | 02/24/2022 |
| K233909 | Argon Medical Devices, Inc. | CleanerÖ Plus 18F Thrombectomy System - CleanerÖ Plus 18F Aspiration Catheter, CleanerÖ Plus 18F Handpiece with Maceration Wire, CleanerÖ Plus 18F Aspiration Canister | 03/28/2024 |
| K232679 | Argon Medical Devices, Inc. | CleanerÖ Pro Thrombectomy System; CleanerÖ Pro Aspiration Catheter with Handpiece; CleanerÖ Pro Aspiration Canister | 01/19/2024 |
| 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 |
| K151313 | BOSTON SCIENTIFIC CORPORATION | ZelanteDVT Thrombectomy Set | 09/21/2015 |
| K202218 | Boston Scientific Corporation | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device | 10/02/2020 |
| K220270 | C.R. Bard, Inc. | Aspirex Thrombectomy System | 06/21/2022 |
| K230356 | C.R. Bard, Inc. | AspirexÖ Thrombectomy System | 03/31/2023 |
| K132281 | Codman & Shurtleff, Inc. | ReVive PV (Peripheral Vasculature) Thrombectomy Device | 08/30/2013 |
| K223897 | Contego Medical Inc. | Excipio LV Thrombectomy Device | 02/17/2023 |
| K221204 | Contego Medical Inc. | Excipio SV Thrombectomy Device | 06/23/2022 |
| K251485 | Contego Medical, Inc. | Excipio LV Prime Thrombectomy Device | 06/13/2025 |
| K230030 | Contego Medical, Inc. | Excipio SV Aspiration Catheter and Tubing | 05/30/2023 |
| K221391 | DeVoro Medical, Inc | WOLF ThrombectomyÖ SmartClaw Catheter | 11/10/2022 |
| K241207 | DeVoro Medical, Inc. | SmartClawÖ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClawÖ Thrombectomy Catheter, 32 mm (FD0660-02) | 05/29/2024 |
| K210911 | DeVoro Medical, Inc. | WOLF Thrombectomy System, 14F | 10/19/2021 |
| K210530 | DeVoro Medical, Inc. | WOLF Thrombectomy System, 6F | 08/27/2021 |
| K200101 | DeVoro Medical, Inc. | WOLF Thrombectomy V System | 04/27/2020 |
| K223891 | Endovascular Engineering | Cobra Catheter System | 02/15/2023 |
| K234073 | Expanse Medical Inc. | ICE Aspiration System | 04/19/2024 |
| 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 |
| K230743 | ICHOR | ICHOR 14F Embolectomy System | 09/05/2023 |
| K233917 | ICHOR | ICHOR 7F Embolectomy System (ICH-7F) | 07/18/2024 |
| K182167 | ICHOR Vascular, Inc. | The ICHOR Panacea Vascular Embolectomy Catheter System | 12/21/2018 |
| K041374 | IDEV TECHNOLOGIES, INC. | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 | 03/02/2005 |
| K250775 | Imperative Care, Inc. | SymphonyÖ Thrombectomy System; SymphonyÖ 16F 82cm Thrombectomy System | 05/14/2025 |
| K223436 | Inari Medical | Artix AX | 03/02/2023 |
| K223000 | Inari Medical | Artix BG | 01/11/2023 |
| K230912 | Inari Medical | Artix BG | 05/02/2023 |
| K220600 | Inari Medical | Artix Thrombectomy Device | 03/25/2022 |
| K193462 | Inari Medical | ClotTriever Thrombectomy System | 09/09/2020 |
| K192036 | Inari Medical | ClotTriever Thrombectomy System | 08/29/2019 |
| K182531 | Inari Medical | ClotTriever Thrombectomy System | 10/10/2018 |
| K173470 | Inari Medical | ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath | 12/04/2017 |
| K192332 | Inari Medical | ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath | 09/20/2019 |
| K201541 | Inari Medical | FlowTriever Retrieval/Aspiration System | 12/04/2020 |
| K202345 | Inari Medical | FlowTriever Retrieval/Aspiration System | 12/18/2020 |
| K181694 | Inari Medical | FlowTriever Retrieval/Aspiration System | 07/27/2018 |
| K182233 | Inari Medical | FlowTriever Retrieval/Aspiration System | 10/15/2018 |
| K183198 | Inari Medical | FlowTriever Retrieval/Aspiration System | 12/17/2018 |
| K191368 | Inari Medical | FlowTriever Retrieval/Aspiration System | 06/17/2019 |
| K191710 | Inari Medical | FlowTriever Retrieval/Aspiration System | 09/05/2019 |
| 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 |
| K220887 | Inari Medical | Mini-ClotTriever Thrombectomy System | 08/04/2022 |
| K152097 | INARI MEDICAL | Retraction Aspirator | 08/25/2015 |
| K210195 | Inari Medical | Triever Catheters | 02/24/2021 |
| K223419 | Inari Medical | Triever16 Curve | 03/23/2023 |
| K213402 | Inari Medical | Triever24, Triever20 | 05/23/2022 |
| K223613 | Inari Medical, Inc | InThrill Thrombectomy System | 03/17/2023 |
| K241894 | Inari Medical, Inc. | ArtixÖ MT; ArtixÖ Thin-Walled Thrombectomy Sheath | 10/15/2024 |
| K230494 | Inari Medical, Inc. | ClotTriever BOLD Catheter | 04/18/2023 |
| K233815 | Inari Medical, Inc. | ClotTriever Sheath | 12/18/2023 |
| K221531 | Inari Medical, Inc. | ClotTriever Thrombectomy System | 02/06/2023 |
| K210689 | Inari Medical, Inc. | ClotTriever Thrombectomy System | 05/12/2021 |
| K212632 | Inari Medical, Inc. | ClotTriever Thrombectomy System | 10/18/2021 |
| K180329 | Inari Medical, Inc. | ClotTriever Thrombectomy System | 04/09/2018 |
| K163549 | Inari Medical, Inc. | ClotTriever Thrombectomy System | 02/16/2017 |
| K223210 | Inari Medical, Inc. | ClotTriever XL Catheter | 04/27/2023 |
| K242557 | Inari Medical, Inc. | ClotTriever XL Catheter (41-102) | 09/27/2024 |
| K181325 | Inari Medical, Inc. | FlowTriever Retrieval/Aspiration System | 06/17/2018 |
| K180466 | Inari Medical, Inc. | FlowTriever Retrieval/Aspiration System | 05/17/2018 |
| K211013 | Inari Medical, Inc. | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 | 04/30/2021 |
| K250088 | Inari Medical, Inc. | FlowTriever2 Catheter | 03/13/2025 |
| K143563 | Inari Medical, Inc. | Infusion Aspiration Catheter System | 02/03/2015 |
| K250421 | Inari Medical, Inc. | InThrillÖ Thrombectomy System | 05/12/2025 |
| K220415 | Inari Medical, Inc. | Protrieve Sheath | 07/12/2022 |
| K230331 | Inari Medical, Inc. | Protrieve Sheath | 03/07/2023 |
| K223609 | Inari Medical, Inc. | RevCoreÖ Thrombectomy Catheter. | 03/14/2023 |
| K231848 | Inari Medical, Inc. | Triever20 Curve (21-201) | 07/21/2023 |
| K203333 | Inari Medical, Inc. | Triever20 Curve Catheter | 12/10/2020 |
| K234034 | Inari Medical, Inc. | VenaCore Thrombectomy Catheter (46-101) | 02/09/2024 |
| K223929 | Innova Vascular, Inc. | LagunaÖ Clot Retriever System and MalibuÖ Aspiration Catheter System (Laguna Thrombectomy System) | 06/01/2023 |
| K250202 | Inquis Medical | Aventus Thrombectomy System | 02/26/2025 |
| K251189 | Inquis Medical | Aventus Thrombectomy System | 06/13/2025 |
| K232730 | Inquis Medical | Aventus Thrombectomy System | 11/01/2023 |
| K240117 | Inquis Medical | Aventus Thrombectomy System (IM-2001/IM-0002) | 03/15/2024 |
| K250668 | Inquis Medical | Aventus Thrombectomy System (IM-2100) | 03/25/2025 |
| K210190 | Irani Medical, Inc. | ClotTriever Thrombectomy System | 02/23/2021 |
| K180722 | KP Medcure, Inc. | CAPERE Thrombectomy System | 06/11/2018 |
| K080901 | LUMEN BIOMEDICAL, INC. | LBI EMBOLECTOMY SYSTEM | 10/02/2008 |
| K130381 | MEDRAD, INC. | ANGIOJET ULTRA POWER PULSE KIT | 07/29/2013 |
| K250787 | Medtronic, Ireland | Liberant Thrombectomy System | 06/11/2025 |
| K991093 | METAMORPHIC SURGICAL DEVICES, LLC. | MSD EMBOLECTOMY BASKET | 12/21/2000 |
| K090932 | NEXGEN MEDICAL SYSTEMS, INC. | NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 | 09/24/2009 |
| K192981 | Penumbra, Inc | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | 05/28/2020 |
| K161523 | Penumbra, Inc. | INDIGO Aspiration System | 07/01/2016 |
| K192833 | Penumbra, Inc. | Indigo Aspiration System | 12/20/2019 |
| K202821 | Penumbra, Inc. | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | 11/18/2020 |
| K193595 | Penumbra, Inc. | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 | 08/19/2020 |
| K210323 | Penumbra, Inc. | Indigo Aspiration System - Lightning Aspiration Tubing | 02/26/2021 |
| K222358 | Penumbra, Inc. | Indigo Aspiration System - Lightning Flash | 12/20/2022 |
| 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 |
| K180412 | Penumbra, Inc. | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister | 05/15/2018 |
| K220683 | Penumbra, Inc. | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | 10/04/2022 |
| K200771 | Penumbra, Inc. | Indigo Aspiration System Lightning Aspiration Tubing | 04/22/2020 |
| K193244 | Penumbra, Inc. | Indigo Aspiration System û Lightning Aspiration Tubing | 03/13/2020 |
| K210083 | Penumbra, Inc. | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 | 02/09/2021 |
| K240030 | Penumbra, Inc. | Indigo« Aspiration System - Lightning« Flash | 02/02/2024 |
| K242319 | Penumbra, Inc. | Indigo« Aspiration System û Aspiration Catheter 6X | 09/03/2024 |
| K242075 | Penumbra, Inc. | Indigo« Aspiration System û Lightning Bolt Aspiration Tubing | 09/25/2024 |
| K223186 | Penumbra, Inc. | Indigo« Aspiration System û Lightning Bolt Aspiration Tubing | 02/13/2023 |
| K241399 | Penumbra, Inc. | Indigo« Lightning Flash Aspiration System û Select +Ö Catheter | 06/10/2024 |
| 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 Aspiration System] | 05/26/2015 |
| K133629 | POSSIS MEDICAL, INC. | ANGIOJET ULTRA AVX THROMBECTOMY SET | 02/14/2014 |
| K141617 | REX MEDICAL, L.P. | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | 11/14/2014 |
| K220501 | Surmodics Inc. | Pounce Thrombectomy System | 03/23/2022 |
| K241362 | Surmodics Inc. | Pounce XL Thrombectomy System (PTS-1011-7F135) | 09/11/2024 |
| K231022 | Surmodics Inc. | PounceÖ Thrombectomy System | 06/12/2023 |
| K211492 | Surmodics, Inc. | Pounce Thrombectomy System | 07/30/2021 |
| K192814 | Surmodics, Inc. | Pounce Thrombus Retrieval System | 09/21/2020 |
| K214114 | Truvic Medical Inc. | Prodigy Thrombectomy System | 04/06/2022 |
| K223216 | Truvic Medical Inc. | Symphony Thrombectomy System | 02/23/2023 |
| K172716 | V2K Medical Inc. | V2K Rinspiration System | 01/26/2018 |
| K203476 | Vascular Medcure, INC. | CAPERE Thrombectomy System | 12/22/2020 |
| K183179 | Vascular Medcure, Inc. | CAPERE Thrombectomy System | 02/25/2019 |
| K192935 | Vascular Medcure, Inc. | CAPERE Thrombectomy System | 11/15/2019 |
| K200314 | Vascular Medcure, Inc. | Capere Thrombectomy System | 03/04/2020 |
| K201216 | Vascular Medcure, Inc. | CAPERE Thrombectomy System | 07/08/2020 |
| K201085 | Vesalio | NeVa PV Thrombectomy Device | 01/15/2021 |
| K201705 | Vetex Medical, Ltd. | ReVene Thrombectomy Catheter | 12/22/2020 |
| K021641 | XTRAK MEDICAL INC. | XTD THROMBECTOMY CATHETER, XX CM | 07/26/2002 |
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