Product code QEW
- Device name
- Peripheral Mechanical Thrombectomy With Aspiration
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5150
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260599 | INDIGO® Aspiration System – INDIGO Link | Penumbra, Inc. | 2026-04-24 |
| K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister | Argon Medical Devices, Inc. | 2026-02-05 |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. | 2026-02-05 |
| K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026-01-21 |
| K251207 | Sangria™ Thrombectomy System | Avantec Vascular Corporation | 2026-01-07 |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2025-12-18 |
| K251070 | Akura Thrombectomy System | Akura Medical | 2025-11-25 |
| K253323 | Protrieve Sheath | Inari Medical | 2025-10-29 |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | 2025-10-22 |
| K252612 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2025-10-16 |
| K252057 | Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System | Imperative Care, Inc. | 2025-08-28 |
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | 2025-06-13 |
| K251189 | Aventus Thrombectomy System | Inquis Medical | 2025-06-13 |
| K250787 | Liberant Thrombectomy System | Medtronic, Ireland | 2025-06-11 |
| K250775 | Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System | Imperative Care, Inc. | 2025-05-14 |
| K250421 | InThrill™ Thrombectomy System | Inari Medical, Inc. | 2025-05-12 |
| K250668 | Aventus Thrombectomy System (IM-2100) | Inquis Medical | 2025-03-25 |
| K250088 | FlowTriever2 Catheter | Inari Medical, Inc. | 2025-03-13 |
| K250202 | Aventus Thrombectomy System | Inquis Medical | 2025-02-26 |
| K241894 | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | 2024-10-15 |
| K242557 | ClotTriever XL Catheter (41-102) | Inari Medical, Inc. | 2024-09-27 |
| K242075 | Indigo® Aspiration System – Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2024-09-25 |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics,Inc. | 2024-09-11 |
| K242319 | Indigo® Aspiration System – Aspiration Catheter 6X | Penumbra, Inc. | 2024-09-03 |
| K233917 | ICHOR 7F Embolectomy System (ICH-7F) | Ichor | 2024-07-18 |
| K241399 | Indigo® Lightning Flash Aspiration System – Select +™ Catheter | Penumbra, Inc. | 2024-06-10 |
| K241207 | SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) | Devoro Medical, Inc. | 2024-05-29 |
| K234073 | ICE Aspiration System | Expanse Medical, Inc. | 2024-04-19 |
| 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 |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002) | Inquis Medical | 2024-03-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850083646066 | enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wire | Vesalio | 2026-03-20 |
| 00850083646059 | enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wire | Vesalio | 2026-03-20 |
| 00850083646042 | enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire | Vesalio | 2026-03-20 |
| 00850083646028 | enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wire | Vesalio | 2026-03-20 |
| 00850044140015 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2026-03-13 |
| 00860008103871 | Recana Introducer Sheath, 16Fr x 90cm | Intervene, Inc. | 2026-03-02 |
| 00860008103864 | Recana Introducer Sheath, 16Fr x 30cm | Intervene, Inc. | 2026-03-02 |
| 00860008103857 | Recana Introducer Sheath, 13Fr x 90cm | Intervene, Inc. | 2026-03-02 |
| 00860008103840 | Recana Introducer Sheath, 13Fr x 30cm | Intervene, Inc. | 2026-03-02 |
| 00860008103833 | Recana Collection Basket, 30mm | Intervene, Inc. | 2026-03-02 |
| 00860008103826 | Recana Collection Basket, 18mm | Intervene, Inc. | 2026-03-02 |
| 00860008103819 | Recana Debulking Catheter | Intervene, Inc. | 2026-03-02 |
| M917RVHD0 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026-02-06 |
| 00850291007697 | Large Bore 60 cc Syringe | Inari Medical, Inc. | 2024-12-20 |
| 00810123710140 | ClotTriever Catheter | Inari Medical, Inc. | 2024-04-17 |
| 00850032079167 | Symphony™ Clot Container | IMPERATIVE CARE, INC. | 2024-02-02 |
| 00850291007369 | InThrill Sheath | Inari Medical, Inc. | 2023-07-18 |
| 00815948024892 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024809 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024816 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024823 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024830 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024847 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024854 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024861 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024878 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00815948024885 | Indigo System | PENUMBRA, INC. | 2023-01-09 |
| 00886333225750 | Cleaner Plus™ | ARGON MEDICAL DEVICES, INC. | 2022-02-28 |
| 08714729968740 | ZelanteDVT™ ClotHunter™ | BOSTON SCIENTIFIC CORPORATION | 2020-11-04 |
| 00850291007109 | ClotTriever Sheath, 13 Fr | Inari Medical, Inc. | 2017-04-19 |