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510(k) K190619

Aspiron(TM) Aspiration Catheter by Meril Life Sciences Private Limited — Product Code QEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2019
Date Received
March 11, 2019
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 Meril Life Sciences Private Limited

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  • K160961 — Mozec NC-Rx PTCA Baloon Dilatation Catheter (July 30, 2016)
  • K131169 — MOZEC - RX PTCA BALLOON DILATATION CATHETER (December 24, 2013)

Other clearances for product code QEZ

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  • K253925 — Aventus Thrombectomy System (January 15, 2026)
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  • 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)