Peripheral Mechanical Thrombectomy With Aspiration
FDA product code QEW · Class II (moderate risk) · 21 CFR 870.5150 · Cardiovascular
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
144510(k) clearances
0PMA approvals
10recalls
Manufacturers
- Inari Medical, Inc. 48
- Penumbra, Inc. 26
- Devoro Medical, Inc. 5
- Surmodics,Inc. 5
- Vascular Medcure, Inc. 5
- Inquis Medical 5
- Contego Medical, Inc. 4
- Argon Medical Devices, Inc 4
- Endovascular Engineering 3
- Genesis Medical Interventional, Inc. 2
- C.R. Bard, Inc. 2
- Imperative Care, Inc. 2
- Ichor 2
- Boston Scientific Corporation 2
- Truvic Medical, Inc. 2
- Codman & Shurtleff, Inc. 1
- Possis Medical, Inc. 1
- Jupiter Endovascular 1
- Lumen Biomedical, Inc. 1
- Idev Technologies, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261800 | Helo Max Thrombectomy System (HEL2090)QEW · Traditional | Endovascular Engineering | 09/03/2026SE |
| K262538 | Artix MT;Artix Thin-Walled SheathQEW · Special | Inari Medical, Inc. | 08/21/2026SE |
| K261523 | Vertex Thrombectomy SystemQEW · Traditional | Jupiter Endovascular | 08/04/2026SE |
| K260599 | INDIGO® Aspiration System INDIGO LinkQEW · Traditional | Penumbra, Inc. | 04/24/2026SE |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece…QEW · Special | Argon Medical Devices, Inc. | 02/05/2026SE |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW · Traditional | Penumbra, Inc. | 02/05/2026SE |
| K253730 | RoVo Mechanical Thrombectomy SystemQEW · Special | Verge Medical, Inc. | 01/21/2026SE |
| K251207 | Sangria Thrombectomy SystemQEW · Traditional | Avantec Vascular Corporation | 01/07/2026SE |
| K252956 | Helo Thrombectomy SystemQEW · Traditional | Endovascular Engineering, Inc. | 12/18/2025SE |
| K251070 | Akura Thrombectomy SystemQEW · Traditional | Akura Medical | 11/25/2025SE |
| K253323 | Protrieve SheathQEW · Special | Inari Medical | 10/29/2025SE |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)QEW · Traditional | Intervene | 10/22/2025SE |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…QEW · Traditional | Penumbra, Inc. | 10/16/2025SE |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy SystemQEW · Traditional | Imperative Care, Inc. | 08/28/2025SE |
| K251485 | Excipio LV Prime Thrombectomy DeviceQEW · Special | Contego Medical, Inc. | 06/13/2025SE |
| K251189 | Aventus Thrombectomy SystemQEW · Traditional | Inquis Medical | 06/13/2025SE |
| K250787 | Liberant Thrombectomy SystemQEW · Traditional | Medtronic, Ireland | 06/11/2025SE |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy SystemQEW · Special | Imperative Care, Inc. | 05/14/2025SE |
| K250421 | InThrill Thrombectomy SystemQEW · Traditional | Inari Medical, Inc. | 05/12/2025SE |
| K250668 | Aventus Thrombectomy System (IM-2100)QEW · Special | Inquis Medical | 03/25/2025SE |
| K250088 | FlowTriever2 CatheterQEW · Traditional | Inari Medical, Inc. | 03/13/2025SE |
| K250202 | Aventus Thrombectomy SystemQEW · Special | Inquis Medical | 02/26/2025SE |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy SheathQEW · Traditional | Inari Medical, Inc. | 10/15/2024SE |
| K242557 | ClotTriever XL Catheter (41-102)QEW · Special | Inari Medical, Inc. | 09/27/2024SE |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration TubingQEW · Traditional | Penumbra, Inc. | 09/25/2024SE |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135)QEW · Traditional | Surmodics,Inc. | 09/11/2024SE |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6XQEW · Special | Penumbra, Inc. | 09/03/2024SE |
| K233917 | ICHOR 7F Embolectomy System (ICH-7F)QEW · Traditional | Ichor | 07/18/2024SE |
| K241399 | Indigo® Lightning Flash Aspiration System Select + CatheterQEW · Special | Penumbra, Inc. | 06/10/2024SE |
| K241207 | SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter…QEW · Special | Devoro Medical, Inc. | 05/29/2024SE |
| K234073 | ICE Aspiration SystemQEW · Traditional | Expanse Medical, Inc. | 04/19/2024SE |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner…QEW · Traditional | Argon Medical Devices, Inc. | 03/28/2024SE |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002)QEW · Traditional | Inquis Medical | 03/15/2024SE |
| K234034 | VenaCore Thrombectomy Catheter (46-101)QEW · Traditional | Inari Medical, Inc. | 02/09/2024SE |
| K240030 | Indigo® Aspiration System - Lightning® FlashQEW · Special | Penumbra, Inc. | 02/02/2024SE |
| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece…QEW · Traditional | Argon Medical Devices, Inc. | 01/19/2024SE |
| K233815 | ClotTriever SheathQEW · Special | Inari Medical, Inc. | 12/18/2023SE |
| K232730 | Aventus Thrombectomy SystemQEW · Traditional | Inquis Medical | 11/01/2023SE |
| K230743 | ICHOR 14F Embolectomy SystemQEW · Traditional | Ichor | 09/05/2023SE |
| K231848 | Triever20 Curve (21-201)QEW · Special | Inari Medical, Inc. | 07/21/2023SE |
| K231022 | Pounce Thrombectomy SystemQEW · Traditional | Surmodics,Inc. | 06/12/2023SE |
| K223929 | Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna…QEW · Traditional | Innova Vascular, Inc. | 06/01/2023SE |
| K230030 | Excipio SV Aspiration Catheter and TubingQEW · Traditional | Contego Medical, Inc. | 05/30/2023SE |
| K230912 | Artix BGQEW · Special | Inari Medical | 05/02/2023SE |
| K223210 | ClotTriever XL CatheterQEW · Traditional | Inari Medical, Inc. | 04/27/2023SE |
| K230494 | ClotTriever BOLD CatheterQEW · Traditional | Inari Medical, Inc. | 04/18/2023SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | C.R. Bard, Inc. | 03/31/2023SE |
| K220780 | ROVO Mechanical Thrombectomy DeviceQEW · Traditional | 2mg, Inc. | 03/31/2023SE |
| K223419 | Triever16 CurveQEW · Special | Inari Medical | 03/23/2023SE |
| K223613 | InThrill Thrombectomy SystemQEW · Traditional | Inari Medical, Inc. | 03/17/2023SE |
| K223609 | RevCore Thrombectomy Catheter.QEW · Traditional | Inari Medical, Inc. | 03/14/2023SE |
| K230331 | Protrieve SheathQEW · Special | Inari Medical, Inc. | 03/07/2023SE |
| K223436 | Artix AXQEW · Special | Inari Medical | 03/02/2023SE |
| K223216 | Symphony Thrombectomy SystemQEW · Traditional | Truvic Medical, Inc. | 02/23/2023SE |
| K223897 | Excipio LV Thrombectomy DeviceQEW · Traditional | Contego Medical, Inc. | 02/17/2023SE |
| K223891 | Cobra Catheter SystemQEW · Traditional | Endovascular Engineering | 02/15/2023SE |
| K223186 | Indigo® Aspiration System Lightning Bolt Aspiration TubingQEW · Traditional | Penumbra, Inc. | 02/13/2023SE |
| K221531 | ClotTriever Thrombectomy SystemQEW · Traditional | Inari Medical, Inc. | 02/06/2023SE |
| K223000 | Artix BGQEW · Traditional | Inari Medical | 01/11/2023SE |
| K222358 | Indigo Aspiration System - Lightning FlashQEW · Traditional | Penumbra, Inc. | 12/20/2022SE |
| K221391 | WOLF Thrombectomy SmartClaw CatheterQEW · Traditional | Devoro Medical, Inc. | 11/10/2022SE |
| K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)QEW · Traditional | Penumbra, Inc. | 10/04/2022SESU |
| K220887 | Mini-ClotTriever Thrombectomy SystemQEW · Traditional | Inari Medical | 08/04/2022SE |
| K220415 | Protrieve SheathQEW · Traditional | Inari Medical, Inc. | 07/12/2022SE |
| K221204 | Excipio SV Thrombectomy DeviceQEW · Traditional | Contego Medical, Inc. | 06/23/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | C.R. Bard, Inc. | 06/21/2022SE |
| K213402 | Triever24, Triever20QEW · Special | Inari Medical | 05/23/2022SE |
| K214114 | Prodigy Thrombectomy SystemQEW · Traditional | Truvic Medical, Inc. | 04/06/2022SE |
| K220600 | Artix Thrombectomy DeviceQEW · Special | Inari Medical | 03/25/2022SE |
| K220501 | Pounce Thrombectomy SystemQEW · Special | Surmodics,Inc. | 03/23/2022SE |
| K211798 | Cleaner Plus Thrombectomy SystemQEW · Traditional | Argon Medical Devices, Inc. | 02/24/2022SE |
| K210911 | WOLF Thrombectomy System, 14FQEW · Traditional | Devoro Medical, Inc. | 10/19/2021SE |
| K212632 | ClotTriever Thrombectomy SystemQEW · Special | Inari Medical, Inc. | 10/18/2021SE |
| K210530 | WOLF Thrombectomy System, 6FQEW · Traditional | Devoro Medical, Inc. | 08/27/2021SE |
| K211492 | Pounce Thrombectomy SystemQEW · Traditional | Surmodics,Inc. | 07/30/2021SE |
| K210689 | ClotTriever Thrombectomy SystemQEW · Traditional | Inari Medical, Inc. | 05/12/2021SE |
| K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20…QEW · Special | Inari Medical, Inc. | 04/30/2021SE |
| K210323 | Indigo Aspiration System - Lightning Aspiration TubingQEW · Special | Penumbra, Inc. | 02/26/2021SE |
| K210195 | Triever CathetersQEW · Special | Inari Medical | 02/24/2021SE |
| K210190 | ClotTriever Thrombectomy SystemQEW · Special | Irani Medical, Inc. | 02/23/2021SE |
| K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7QEW · Special | Penumbra, Inc. | 02/09/2021SE |
| K201085 | NeVa PV Thrombectomy DeviceQEW · Traditional | Vesalio | 01/15/2021SE |
| K203476 | CAPERE Thrombectomy SystemQEW · Special | Vascular Medcure, Inc. | 12/22/2020SE |
| K201705 | ReVene Thrombectomy CatheterQEW · Traditional | Vetex Medical, Ltd. | 12/22/2020SE |
| K202345 | FlowTriever Retrieval/Aspiration SystemQEW · Traditional | Inari Medical | 12/18/2020SE |
| K203333 | Triever20 Curve CatheterQEW · Special | Inari Medical, Inc. | 12/10/2020SE |
| K201541 | FlowTriever Retrieval/Aspiration SystemQEW · Traditional | Inari Medical | 12/04/2020SE |
| K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12QEW · Traditional | Penumbra, Inc. | 11/18/2020SE |
| K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceQEW · Traditional | Boston Scientific Corporation | 10/02/2020SE |
| K192814 | Pounce Thrombus Retrieval SystemQEW · Traditional | Surmodics,Inc. | 09/21/2020SE |
| K193462 | ClotTriever Thrombectomy SystemQEW · Traditional | Inari Medical | 09/09/2020SE |
| K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7QEW · Traditional | Penumbra, Inc. | 08/19/2020SE |
| K201216 | CAPERE Thrombectomy SystemQEW · Special | Vascular Medcure, Inc. | 07/08/2020SE |
| K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12QEW · Traditional | Penumbra, Inc. | 05/28/2020SE |
| K200101 | WOLF Thrombectomy V SystemQEW · Traditional | Devoro Medical, Inc. | 04/27/2020SE |
| K200771 | Indigo Aspiration System Lightning Aspiration TubingQEW · Special | Penumbra, Inc. | 04/22/2020SE |
| K193244 | Indigo Aspiration System Lightning Aspiration TubingQEW · Traditional | Penumbra, Inc. | 03/13/2020SE |
| K200314 | Capere Thrombectomy SystemQEW · Special | Vascular Medcure, Inc. | 03/04/2020SE |
| K192833 | Indigo Aspiration SystemQEW · Traditional | Penumbra, Inc. | 12/20/2019SE |
| K192935 | CAPERE Thrombectomy SystemQEW · Special | Vascular Medcure, Inc. | 11/15/2019SE |
| K192332 | ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever SheathQEW · Special | Inari Medical | 09/20/2019SE |
| K191710 | FlowTriever Retrieval/Aspiration SystemQEW · Traditional | Inari Medical | 09/05/2019SE |
| K192036 | ClotTriever Thrombectomy SystemQEW · Special | Inari Medical | 08/29/2019SE |
| K191368 | FlowTriever Retrieval/Aspiration SystemQEW · Special | Inari Medical | 06/17/2019SE |
| K182835 | WOLF Thrombectomy DeviceQEW · Traditional | 880 Medical, LLC | 03/27/2019SE |
| K183179 | CAPERE Thrombectomy SystemQEW · Traditional | Vascular Medcure, Inc. | 02/25/2019SE |
| K182167 | The ICHOR Panacea Vascular Embolectomy Catheter SystemQEW · Traditional | Ichor Vascular, Inc. | 12/21/2018SE |
| K183198 | FlowTriever Retrieval/Aspiration SystemQEW · Special | Inari Medical | 12/17/2018SE |
| K182233 | FlowTriever Retrieval/Aspiration SystemQEW · Traditional | Inari Medical | 10/15/2018SE |
| K182531 | ClotTriever Thrombectomy SystemQEW · Special | Inari Medical | 10/10/2018SE |
| K181694 | FlowTriever Retrieval/Aspiration SystemQEW · Special | Inari Medical | 07/27/2018SE |
| K181325 | FlowTriever Retrieval/Aspiration SystemQEW · Special | Inari Medical, Inc. | 06/17/2018SE |
| K180722 | CAPERE Thrombectomy SystemQEW · Traditional | Kp Medcure, Inc. | 06/11/2018SE |
| K180466 | FlowTriever Retrieval/Aspiration SystemQEW · Traditional | Inari Medical, Inc. | 05/17/2018SE |
| K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterQEW · Traditional | Penumbra, Inc. | 05/15/2018SE |
| K180939 | Indigo Aspiration System - Modified 110 Aspiration TubingQEW · Special | Penumbra, Inc. | 05/03/2018SE |
| K180329 | ClotTriever Thrombectomy SystemQEW · Special | Inari Medical, Inc. | 04/09/2018SE |
| K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…QEW · Special | Penumbra, Inc. | 03/08/2018SE |
| K173672 | FlowTriever Retrieval/Aspiration System, Aspiration Guide CatheterQEW · Special | Inari Medical | 02/05/2018SE |
| K172716 | V2K Rinspiration SystemQEW · Traditional | V2k Medical, Inc. | 01/26/2018SE |
| K173470 | ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathQEW · Special | Inari Medical | 12/04/2017SE |
| K163549 | ClotTriever Thrombectomy SystemQEW · Traditional | Inari Medical, Inc. | 02/16/2017SE |
| K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorQEW · Special | Inari Medical | 11/22/2016SE |
| K161506 | Penumbra Aspiration SystemQEW · Traditional | Penumbra, Inc. | 09/26/2016SE |
| K161523 | INDIGO Aspiration SystemQEW · Special | Penumbra, Inc. | 07/01/2016SE |
| K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)QEW · Traditional | Penumbra, Inc. | 05/24/2016SE |
| K151313 | ZelanteDVT Thrombectomy SetQEW · Traditional | Boston Scientific Corporation | 09/21/2015SE |
| K152097 | Retraction AspiratorQEW · Special | Inari Medical | 08/25/2015SE |
| K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]QEW · Traditional | Penumbra, Inc. | 05/26/2015SE |
| K143563 | Infusion Aspiration Catheter SystemQEW · Traditional | Inari Medical, Inc. | 02/03/2015SE |
| K141617 | Cleaner Rotational Thrombectomy SystemQEW · Traditional | Rex Medical, L.P. | 11/14/2014SE |
| K133629 | Angiojet Ultra Avx Thrombectomy SetQEW · Special | Possis Medical, Inc. | 02/14/2014SE |
| K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy DeviceQEW · Special | Codman & Shurtleff, Inc. | 08/30/2013SE |
| K130381 | Angiojet Ultra Power Pulse KitQEW · Traditional | Medrad, Inc. | 07/29/2013SE |
| K121917 | Penumbra Embolectomy Aspiration SystemQEW · Traditional | Penumbra, Inc. | 09/19/2012SE |
| K092623 | F.A.S.T. System Sed and CXDQEW · Special | Genesis Medical Interventional, Inc. | 10/30/2009SE |
| K090932 | Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80 CM, Model…QEW · Traditional | Nexgen Medical Systems, Inc. | 09/24/2009SE |
| K083370 | D-Clot Thrombectomy Catheter System, Model: DC 4006QEW · Special | Artegraft, Inc. | 12/12/2008SE |
| K080901 | Lbi Embolectomy SystemQEW · Traditional | Lumen Biomedical, Inc. | 10/02/2008SESU |
| K041374 | Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060QEW · Traditional | Idev Technologies, Inc. | 03/02/2005SE |
| K040010 | Genesis Medical Interventional F.A.S.T. (Facilitated Aspiration/Suction Thrombectomy)…QEW · Traditional | Genesis Medical Interventional, Inc. | 07/19/2004SE |
| K021641 | XTD Thrombectomy Catheter, XX CMQEW · Special | Xtrak Medical, Inc. | 07/26/2002SE |
| K011056 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTDQEW · Traditional | Arrow Intl., Inc. | 10/24/2001SE |
| K991093 | MSD Embolectomy BasketQEW · Traditional | Metamorphic Surgical Devices, LLC | 12/21/2000SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1728-2025 Class II | Artix MT Thrombectomy Device, REF: 32-102Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather… | Inari Medical - Oak Canyon | 04/08/2025Open, Classified |
| Z-2587-2024 Class I | ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever…Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following… | Inari Medical - Oak Canyon | 07/19/2024Open, Classified |
| Z-2213-2024 Class II | The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system…Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may… | Mermaid Medical A/S | 05/01/2024Open, Classified |
| Z-0629-2022 Class I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good…The firm received reports indicating PTD tip separation during use. | Teleflex Medical Inc | 01/11/2022Terminated |
| Z-0628-2022 Class I | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF…The firm received reports indicating PTD tip separation during use. | Teleflex Medical Inc | 01/11/2022Terminated |
| Z-0627-2022 Class I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing…The firm received reports indicating PTD tip separation during use. | Teleflex Medical Inc | 01/11/2022Terminated |
| Z-0626-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC…The firm received reports indicating PTD tip separation during use. | Teleflex Medical Inc | 01/11/2022Terminated |
| Z-0625-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W…The firm received reports indicating PTD tip separation during use. | Teleflex Medical Inc | 01/11/2022Terminated |
| Z-0624-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF…The firm received reports indicating PTD tip separation during use. | Teleflex Medical Inc | 01/11/2022Terminated |
| Z-0623-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF…The firm received reports indicating PTD tip separation during use. | Teleflex Medical Inc | 01/11/2022Terminated |