Home / 510(k) Clearances / K250668

510(k) K250668

Aventus Thrombectomy System (IM-2100) by Inquis Medical — Product Code QEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2025
Date Received
March 5, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peripheral Mechanical Thrombectomy With Aspiration
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.

Other clearances by Inquis Medical

  • K253925 — Aventus Thrombectomy System (January 15, 2026)
  • K251189 — Aventus Thrombectomy System (June 13, 2025)
  • K250202 — Aventus Thrombectomy System (February 26, 2025)
  • K240426 — Aventus Clot Management System (May 14, 2024)
  • K240117 — Aventus Thrombectomy System (IM-2001/IM-0002) (March 15, 2024)
  • K232730 — Aventus Thrombectomy System (November 1, 2023)

Other clearances for product code QEW

  • K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (February 5, 2026)
  • K260028 — CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiec (February 5, 2026)
  • K253730 — RoVo Mechanical Thrombectomy System (January 21, 2026)
  • K251207 — Sangria™ Thrombectomy System (January 7, 2026)
  • K252956 — Helo Thrombectomy System (December 18, 2025)
  • K251070 — Akura Thrombectomy System (November 25, 2025)
  • K253323 — Protrieve Sheath (October 29, 2025)
  • K251185 — Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, F (October 22, 2025)
  • K252612 — INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiratio (October 16, 2025)
  • K252057 — Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (August 28, 2025)