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510(k) K213565

JETi AIO Peripheral Thrombectomy System by Walk Vascular, LLC — Product Code QEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2022
Date Received
November 9, 2021
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 Walk Vascular, LLC

  • K201998 — JETi AIO Peripheral Thrombectomy System (November 17, 2020)
  • K192439 — JETi Peripheral Thrombectomy System (December 9, 2019)
  • K183403 — JETi 88 Peripheral Thrombectomy System (April 17, 2019)
  • K172000 — ClearLumen II Peripheral Thrombectomy System (October 24, 2017)
  • K163051 — ClearLumen II Peripheral Thrombectomy System (February 21, 2017)
  • K161786 — ClearLumen II Thrombectomy System (October 18, 2016)
  • K140296 — CLEARLUMEN THROMBECTOMY SYSTEM (December 2, 2014)
  • K120508 — CLEARLUMEN THROMBECTOMY SYSTEM (November 7, 2012)

Other clearances for product code QEZ

  • K253925 — Aventus Thrombectomy System (January 15, 2026)
  • 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)
  • K212199 — ASAP Aspiration Catheter, ASAPLP Aspiration Catheter (November 3, 2021)