QEW — Peripheral Mechanical Thrombectomy With Aspiration Class II
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 |
|---|---|---|---|
| K260028 | argon medical devices | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiec | February 5, 2026 |
| K251949 | penumbra | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | 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 |
| K242557 | inari medical | ClotTriever XL Catheter (41-102) | September 27, 2024 |