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510(k) K211081

AlphaVac Multipurpose Mechanical Aspiration (MMA) System by AngioDynamics, Inc. — Product Code QEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2021
Date Received
April 12, 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 AngioDynamics, Inc.

  • K252509 — AlphaVac Multipurpose Mechanical Aspiration System F1885 (November 24, 2025)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K242687 — NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Pro (December 6, 2024)
  • K240397 — AlphaVac MMA F1885 System (H787253020) (April 1, 2024)
  • K231945 — VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedu (July 20, 2023)
  • K223581 — Solero Microwave Tissue Ablation (MTA) System and Accessories (March 27, 2023)
  • K221883 — Solero Microwave Tissue Ablation (MTA) System and Accessories (March 7, 2023)
  • K213388 — AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (April 4, 2022)
  • K213067 — Solero Microwave Tissue Ablation (MTA) System and Accessories (December 3, 2021)
  • K212386 — AngioVac F18 85 (September 30, 2021)

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)
  • K213565 — JETi AIO Peripheral Thrombectomy System (February 1, 2022)