QEW — Peripheral Mechanical Thrombectomy With Aspiration Class II
FDA product code QEW covers "Peripheral Mechanical Thrombectomy With Aspiration", a Class II medical device regulated under 21 CFR 870.5150. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QEW
- Device Class
- Class II
- Regulation Number
- 870.5150
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260599 | penumbra | INDIGO® Aspiration System INDIGO Link | April 24, 2026 |
| K251949 | penumbra | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | February 5, 2026 |
| K260028 | argon medical devices | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiec | February 5, 2026 |
| K253730 | verge medical | RoVo Mechanical Thrombectomy System | January 21, 2026 |
| K251207 | avantec vascular corporation | Sangria Thrombectomy System | January 7, 2026 |
| K252956 | endovascular engineering | Helo Thrombectomy System | December 18, 2025 |
| K251070 | akura medical | Akura Thrombectomy System | November 25, 2025 |
| K253323 | inari medical | Protrieve Sheath | October 29, 2025 |
| K251185 | intervene | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, F | October 22, 2025 |
| K252612 | penumbra | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiratio | October 16, 2025 |
| K252057 | imperative care | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | August 28, 2025 |
| K251485 | contego medical | Excipio LV Prime Thrombectomy Device | June 13, 2025 |
| K251189 | inquis medical | Aventus Thrombectomy System | June 13, 2025 |
| K250787 | medtronic, ireland | Liberant Thrombectomy System | June 11, 2025 |
| K250775 | imperative care | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | May 14, 2025 |
| K250421 | inari medical | InThrill Thrombectomy System | May 12, 2025 |
| K250668 | inquis medical | Aventus Thrombectomy System (IM-2100) | March 25, 2025 |
| K250088 | inari medical | FlowTriever2 Catheter | March 13, 2025 |
| K250202 | inquis medical | Aventus Thrombectomy System | February 26, 2025 |
| K241894 | inari medical | Artix MT; Artix Thin-Walled Thrombectomy Sheath | October 15, 2024 |