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510(k) K253925

Aventus Thrombectomy System by Inquis Medical — Product Code QEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2026
Date Received
December 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspiration Thrombectomy Catheter
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

Other clearances by Inquis Medical

  • K251189 — Aventus Thrombectomy System (June 13, 2025)
  • K250668 — Aventus Thrombectomy System (IM-2100) (March 25, 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 QEZ

  • K252509 — AlphaVac Multipurpose Mechanical Aspiration System F1885 (November 24, 2025)
  • K251312 — Vesalio Peripheral System (October 24, 2025)
  • K251488 — FLOWRUNNER Aspiration System (July 14, 2025)
  • K243549 — JETi Hydrodynamic Thrombectomy System (April 4, 2025)
  • K250013 — VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP (March 24, 2025)
  • K240397 — AlphaVac MMA F1885 System (H787253020) (April 1, 2024)
  • K232458 — JETi™Hydrodynamic Thrombectomy System (December 19, 2023)
  • K213388 — AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (April 4, 2022)
  • K213565 — JETi AIO Peripheral Thrombectomy System (February 1, 2022)
  • K212199 — ASAP Aspiration Catheter, ASAPLP Aspiration Catheter (November 3, 2021)