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 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253419 | Triever Duo Catheter | Inari Medical, Inc. | 2026-09-18 | Traditional | PDF ↗ |
| K261800 | Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering | 2026-09-03 | Traditional | PDF ↗ |
| K262538 | Artix MT;Artix Thin-Walled Sheath | Inari Medical, Inc. | 2026-08-21 | Special | PDF ↗ |
| K261523 | Vertex Thrombectomy System | Jupiter Endovascular | 2026-08-04 | Traditional | PDF ↗ |
| K260599 | INDIGO® Aspiration System INDIGO Link | Penumbra, Inc. | 2026-04-24 | Traditional | PDF ↗ |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. | 2026-02-05 | Traditional | PDF ↗ |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | Argon Medical Devices, Inc. | 2026-02-05 | Special | PDF ↗ |
| K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026-01-21 | Special | PDF ↗ |
| K251207 | Sangria Thrombectomy System | Avantec Vascular Corporation | 2026-01-07 | Traditional | PDF ↗ |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2025-12-18 | Traditional | PDF ↗ |
| K251070 | Akura Thrombectomy System | Akura Medical | 2025-11-25 | Traditional | PDF ↗ |
| K253323 | Protrieve Sheath | Inari Medical | 2025-10-29 | Special | PDF ↗ |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | 2025-10-22 | Traditional | PDF ↗ |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2025-10-16 | Traditional | PDF ↗ |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. | 2025-08-28 | Traditional | PDF ↗ |
| K251189 | Aventus Thrombectomy System | Inquis Medical | 2025-06-13 | Traditional | PDF ↗ |
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | 2025-06-13 | Special | PDF ↗ |
| K250787 | Liberant Thrombectomy System | Medtronic, Ireland | 2025-06-11 | Traditional | PDF ↗ |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. | 2025-05-14 | Special | PDF ↗ |
| K250421 | InThrill Thrombectomy System | Inari Medical, Inc. | 2025-05-12 | Traditional | PDF ↗ |
| K250668 | Aventus Thrombectomy System (IM-2100) | Inquis Medical | 2025-03-25 | Special | PDF ↗ |
| K250088 | FlowTriever2 Catheter | Inari Medical, Inc. | 2025-03-13 | Traditional | PDF ↗ |
| K250202 | Aventus Thrombectomy System | Inquis Medical | 2025-02-26 | Special | PDF ↗ |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | 2024-10-15 | Traditional | PDF ↗ |
| K242557 | ClotTriever XL Catheter (41-102) | Inari Medical, Inc. | 2024-09-27 | Special | PDF ↗ |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2024-09-25 | Traditional | PDF ↗ |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics,Inc. | 2024-09-11 | Traditional | PDF ↗ |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6X | Penumbra, Inc. | 2024-09-03 | Special | PDF ↗ |
| K233917 | ICHOR 7F Embolectomy System (ICH-7F) | Ichor | 2024-07-18 | Traditional | PDF ↗ |
| K241399 | Indigo® Lightning Flash Aspiration System Select + Catheter | Penumbra, Inc. | 2024-06-10 | Special | PDF ↗ |
| K241207 | SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02) | Devoro Medical, Inc. | 2024-05-29 | Special | PDF ↗ |
| K234073 | ICE Aspiration System | Expanse Medical, Inc. | 2024-04-19 | Traditional | PDF ↗ |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister | Argon Medical Devices, Inc. | 2024-03-28 | Traditional | PDF ↗ |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002) | Inquis Medical | 2024-03-15 | Traditional | PDF ↗ |
| K234034 | VenaCore Thrombectomy Catheter (46-101) | Inari Medical, Inc. | 2024-02-09 | Traditional | PDF ↗ |
| K240030 | Indigo® Aspiration System - Lightning® Flash | Penumbra, Inc. | 2024-02-02 | Special | PDF ↗ |
| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister | Argon Medical Devices, Inc. | 2024-01-19 | Traditional | PDF ↗ |
| K233815 | ClotTriever Sheath | Inari Medical, Inc. | 2023-12-18 | Special | PDF ↗ |
| K232730 | Aventus Thrombectomy System | Inquis Medical | 2023-11-01 | Traditional | PDF ↗ |
| K230743 | ICHOR 14F Embolectomy System | Ichor | 2023-09-05 | Traditional | PDF ↗ |
| K231848 | Triever20 Curve (21-201) | Inari Medical, Inc. | 2023-07-21 | Special | PDF ↗ |
| K231022 | Pounce Thrombectomy System | Surmodics,Inc. | 2023-06-12 | Traditional | PDF ↗ |
| K223929 | Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System) | Innova Vascular, Inc. | 2023-06-01 | Traditional | PDF ↗ |
| K230030 | Excipio SV Aspiration Catheter and Tubing | Contego Medical, Inc. | 2023-05-30 | Traditional | PDF ↗ |
| K230912 | Artix BG | Inari Medical | 2023-05-02 | Special | PDF ↗ |
| K223210 | ClotTriever XL Catheter | Inari Medical, Inc. | 2023-04-27 | Traditional | PDF ↗ |
| K230494 | ClotTriever BOLD Catheter | Inari Medical, Inc. | 2023-04-18 | Traditional | PDF ↗ |
| K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023-03-31 | Traditional | PDF ↗ |
| K230356 | Aspirex Thrombectomy System | C.R. Bard, Inc. | 2023-03-31 | Traditional | PDF ↗ |
| K223419 | Triever16 Curve | Inari Medical | 2023-03-23 | Special | PDF ↗ |
| K223613 | InThrill Thrombectomy System | Inari Medical, Inc. | 2023-03-17 | Traditional | PDF ↗ |
| K223609 | RevCore Thrombectomy Catheter. | Inari Medical, Inc. | 2023-03-14 | Traditional | PDF ↗ |
| K230331 | Protrieve Sheath | Inari Medical, Inc. | 2023-03-07 | Special | PDF ↗ |
| K223436 | Artix AX | Inari Medical | 2023-03-02 | Special | PDF ↗ |
| K223216 | Symphony Thrombectomy System | Truvic Medical, Inc. | 2023-02-23 | Traditional | PDF ↗ |
| K223897 | Excipio LV Thrombectomy Device | Contego Medical, Inc. | 2023-02-17 | Traditional | PDF ↗ |
| K223891 | Cobra Catheter System | Endovascular Engineering | 2023-02-15 | Traditional | PDF ↗ |
| K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2023-02-13 | Traditional | PDF ↗ |
| K221531 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2023-02-06 | Traditional | PDF ↗ |
| K223000 | Artix BG | Inari Medical | 2023-01-11 | Traditional | PDF ↗ |
| K222358 | Indigo Aspiration System - Lightning Flash | Penumbra, Inc. | 2022-12-20 | Traditional | PDF ↗ |
| K221391 | WOLF Thrombectomy SmartClaw Catheter | Devoro Medical, Inc. | 2022-11-10 | Traditional | PDF ↗ |
| K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | Penumbra, Inc. | 2022-10-04 | Traditional | PDF ↗ |
| K220887 | Mini-ClotTriever Thrombectomy System | Inari Medical | 2022-08-04 | Traditional | PDF ↗ |
| K220415 | Protrieve Sheath | Inari Medical, Inc. | 2022-07-12 | Traditional | PDF ↗ |
| K221204 | Excipio SV Thrombectomy Device | Contego Medical, Inc. | 2022-06-23 | Traditional | PDF ↗ |
| K220270 | Aspirex Thrombectomy System | C.R. Bard, Inc. | 2022-06-21 | Traditional | PDF ↗ |
| K213402 | Triever24, Triever20 | Inari Medical | 2022-05-23 | Special | PDF ↗ |
| K214114 | Prodigy Thrombectomy System | Truvic Medical, Inc. | 2022-04-06 | Traditional | PDF ↗ |
| K220600 | Artix Thrombectomy Device | Inari Medical | 2022-03-25 | Special | PDF ↗ |
| K220501 | Pounce Thrombectomy System | Surmodics,Inc. | 2022-03-23 | Special | PDF ↗ |
| K211798 | Cleaner Plus Thrombectomy System | Argon Medical Devices, Inc. | 2022-02-24 | Traditional | PDF ↗ |
| K210911 | WOLF Thrombectomy System, 14F | Devoro Medical, Inc. | 2021-10-19 | Traditional | PDF ↗ |
| K212632 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021-10-18 | Special | PDF ↗ |
| K210530 | WOLF Thrombectomy System, 6F | Devoro Medical, Inc. | 2021-08-27 | Traditional | PDF ↗ |
| K211492 | Pounce Thrombectomy System | Surmodics,Inc. | 2021-07-30 | Traditional | PDF ↗ |
| K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021-05-12 | Traditional | PDF ↗ |
| K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 | Inari Medical, Inc. | 2021-04-30 | Special | PDF ↗ |
| K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | Penumbra, Inc. | 2021-02-26 | Special | PDF ↗ |
| K210195 | Triever Catheters | Inari Medical | 2021-02-24 | Special | PDF ↗ |
| K210190 | ClotTriever Thrombectomy System | Irani Medical, Inc. | 2021-02-23 | Special | PDF ↗ |
| K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 | Penumbra, Inc. | 2021-02-09 | Special | PDF ↗ |
| K201085 | NeVa PV Thrombectomy Device | Vesalio | 2021-01-15 | Traditional | PDF ↗ |
| K201705 | ReVene Thrombectomy Catheter | Vetex Medical, Ltd. | 2020-12-22 | Traditional | PDF ↗ |
| K203476 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2020-12-22 | Special | PDF ↗ |
| K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020-12-18 | Traditional | PDF ↗ |
| K203333 | Triever20 Curve Catheter | Inari Medical, Inc. | 2020-12-10 | Special | PDF ↗ |
| K201541 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020-12-04 | Traditional | PDF ↗ |
| K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | Penumbra, Inc. | 2020-11-18 | Traditional | PDF ↗ |
| K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device | Boston Scientific Corporation | 2020-10-02 | Traditional | PDF ↗ |
| K192814 | Pounce Thrombus Retrieval System | Surmodics,Inc. | 2020-09-21 | Traditional | PDF ↗ |
| K193462 | ClotTriever Thrombectomy System | Inari Medical | 2020-09-09 | Traditional | PDF ↗ |
| K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 | Penumbra, Inc. | 2020-08-19 | Traditional | PDF ↗ |
| K201216 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2020-07-08 | Special | PDF ↗ |
| K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | Penumbra, Inc. | 2020-05-28 | Traditional | PDF ↗ |
| K200101 | WOLF Thrombectomy V System | Devoro Medical, Inc. | 2020-04-27 | Traditional | PDF ↗ |
| K200771 | Indigo Aspiration System Lightning Aspiration Tubing | Penumbra, Inc. | 2020-04-22 | Special | PDF ↗ |
| K193244 | Indigo Aspiration System Lightning Aspiration Tubing | Penumbra, Inc. | 2020-03-13 | Traditional | PDF ↗ |
| K200314 | Capere Thrombectomy System | Vascular Medcure, Inc. | 2020-03-04 | Special | PDF ↗ |
| K192833 | Indigo Aspiration System | Penumbra, Inc. | 2019-12-20 | Traditional | PDF ↗ |
Product code QEW · Class II · Cardiovascular. Data: openFDA.