QEW · Peripheral Mechanical Thrombectomy With Aspiration
Cardiovascular · 21 CFR 870.5150 · Class 2
Overview
| Product Code | QEW |
|---|---|
| Device Name | Peripheral Mechanical Thrombectomy With Aspiration |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 140)
Showing 20 most recent of 140 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | Argon Medical Devices, Inc. | Feb 5, 2026 | SESE |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. | Feb 5, 2026 | SESE |
| K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | Jan 21, 2026 | SESE |
| K251207 | Sangria Thrombectomy System | Avantec Vascular Corporation | Jan 7, 2026 | SESE |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | Dec 18, 2025 | SESE |
| K251070 | Akura Thrombectomy System | Akura Medical | Nov 25, 2025 | SESE |
| K253323 | Protrieve Sheath | Inari Medical | Oct 29, 2025 | SESE |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | Oct 22, 2025 | SESE |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | Oct 16, 2025 | SESE |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. | Aug 28, 2025 | SESE |
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | Jun 13, 2025 | SESE |
| K251189 | Aventus Thrombectomy System | Inquis Medical | Jun 13, 2025 | SESE |
| K250787 | Liberant Thrombectomy System | Medtronic, Ireland | Jun 11, 2025 | SESE |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. | May 14, 2025 | SESE |
| K250421 | InThrill Thrombectomy System | Inari Medical, Inc. | May 12, 2025 | SESE |
| K250668 | Aventus Thrombectomy System (IM-2100) | Inquis Medical | Mar 25, 2025 | SESE |
| K250088 | FlowTriever2 Catheter | Inari Medical, Inc. | Mar 13, 2025 | SESE |
| K250202 | Aventus Thrombectomy System | Inquis Medical | Feb 26, 2025 | SESE |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | Oct 15, 2024 | SESE |
| K242557 | ClotTriever XL Catheter (41-102) | Inari Medical, Inc. | Sep 27, 2024 | SESE |
Top Applicants
- Penumbra, Inc. — 25 clearances
- Inari Medical — 24 clearances
- Inari Medical, Inc. — 23 clearances
- Devoro Medical, Inc. — 5 clearances
- Inquis Medical — 5 clearances
