Cleared Traditional

AlphaVac Multipurpose Mechanical Aspiration System F1885

K252509 · AngioDynamics, Inc. · Cardiovascular
Nov 2025
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K252509 is an FDA 510(k) clearance for the AlphaVac Multipurpose Mechanical Aspiration System F1885, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on November 24, 2025, 108 days after receiving the submission on August 8, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K252509 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2025
Decision Date November 24, 2025
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QEZ — Aspiration Thrombectomy Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.

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