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 |
|---|---|---|---|
| Oct 15, 2026 | K262904 | INDIGO® Aspiration System Penumbra, Inc. | QEW |
| Sep 18, 2026 | K253419 | Triever Duo Catheter Inari Medical, Inc. | QEW |
| Sep 3, 2026 | K261800 | Helo Max Thrombectomy System (HEL2090) Endovascular Engineering | QEW |
| Aug 21, 2026 | K262538 | Artix MT;Artix Thin-Walled Sheath Inari Medical, Inc. | QEW |
| Aug 4, 2026 | K261523 | Vertex Thrombectomy System Jupiter Endovascular | QEW |
| Apr 24, 2026 | K260599 | INDIGO® Aspiration System INDIGO Link Penumbra, Inc. | QEW |
| Feb 5, 2026 | K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister Argon Medical Devices, Inc. | QEW |
| Feb 5, 2026 | K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK Penumbra, Inc. | QEW |
| Jan 21, 2026 | K253730 | RoVo Mechanical Thrombectomy System Verge Medical, Inc. | QEW |
| Jan 7, 2026 | K251207 | Sangria Thrombectomy System Avantec Vascular Corporation | QEW |
| Dec 18, 2025 | K252956 | Helo Thrombectomy System Endovascular Engineering, Inc. | QEW |
| Nov 25, 2025 | K251070 | Akura Thrombectomy System Akura Medical | QEW |
| Oct 29, 2025 | K253323 | Protrieve Sheath Inari Medical | QEW |
| Oct 22, 2025 | K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) Intervene | QEW |
| Oct 16, 2025 | K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tub Penumbra, Inc. | QEW |
| Aug 28, 2025 | K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System Imperative Care, Inc. | QEW |
| Jun 13, 2025 | K251485 | Excipio LV Prime Thrombectomy Device Contego Medical, Inc. | QEW |
| Jun 13, 2025 | K251189 | Aventus Thrombectomy System Inquis Medical | QEW |
| Jun 11, 2025 | K250787 | Liberant Thrombectomy System Medtronic, Ireland, IE | QEW |
| May 14, 2025 | K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System Imperative Care, Inc. | QEW |
| May 12, 2025 | K250421 | InThrill Thrombectomy System Inari Medical, Inc. | QEW |
| Mar 25, 2025 | K250668 | Aventus Thrombectomy System (IM-2100) Inquis Medical | QEW |
| Mar 13, 2025 | K250088 | FlowTriever2 Catheter Inari Medical, Inc. | QEW |
| Feb 26, 2025 | K250202 | Aventus Thrombectomy System Inquis Medical | QEW |
| Oct 15, 2024 | K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath Inari Medical, Inc. | QEW |
| Sep 27, 2024 | K242557 | ClotTriever XL Catheter (41-102) Inari Medical, Inc. | QEW |
| Sep 25, 2024 | K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing Penumbra, Inc. | QEW |
| Sep 11, 2024 | K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) Surmodics,Inc. | QEW |
| Sep 3, 2024 | K242319 | Indigo® Aspiration System Aspiration Catheter 6X Penumbra, Inc. | QEW |
| Jul 18, 2024 | K233917 | ICHOR 7F Embolectomy System (ICH-7F) Ichor | QEW |
| Jun 10, 2024 | K241399 | Indigo® Lightning Flash Aspiration System Select + Catheter Penumbra, Inc. | QEW |
| May 29, 2024 | K241207 | SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02) Devoro Medical, Inc. | QEW |
| Apr 19, 2024 | K234073 | ICE Aspiration System Expanse Medical, Inc. | QEW |
| Mar 28, 2024 | K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Macerati Argon Medical Devices, Inc. | QEW |
| Mar 15, 2024 | K240117 | Aventus Thrombectomy System (IM-2001/IM-0002) Inquis Medical | QEW |
| Feb 9, 2024 | K234034 | VenaCore Thrombectomy Catheter (46-101) Inari Medical, Inc. | QEW |
| Feb 2, 2024 | K240030 | Indigo® Aspiration System - Lightning® Flash Penumbra, Inc. | QEW |
| Jan 19, 2024 | K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister Argon Medical Devices, Inc. | QEW |
| Dec 18, 2023 | K233815 | ClotTriever Sheath Inari Medical, Inc. | QEW |
| Nov 1, 2023 | K232730 | Aventus Thrombectomy System Inquis Medical | QEW |
| Sep 5, 2023 | K230743 | ICHOR 14F Embolectomy System Ichor | QEW |
| Jul 21, 2023 | K231848 | Triever20 Curve (21-201) Inari Medical, Inc. | QEW |
| Jun 12, 2023 | K231022 | Pounce Thrombectomy System Surmodics,Inc. | QEW |
| Jun 1, 2023 | K223929 | Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System) Innova Vascular, Inc. | QEW |
| May 30, 2023 | K230030 | Excipio SV Aspiration Catheter and Tubing Contego Medical, Inc. | QEW |
| May 2, 2023 | K230912 | Artix BG Inari Medical | QEW |
| Apr 27, 2023 | K223210 | ClotTriever XL Catheter Inari Medical, Inc. | QEW |
| Apr 18, 2023 | K230494 | ClotTriever BOLD Catheter Inari Medical, Inc. | QEW |
| Mar 31, 2023 | K230356 | Aspirex Thrombectomy System C.R. Bard, Inc. | QEW |
| Mar 31, 2023 | K220780 | ROVO Mechanical Thrombectomy Device 2mg, Inc. | QEW |
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