Cleared Traditional

AlphaVac MMA F1885 System (H787253020)

K240397 · AngioDynamics, Inc. · Cardiovascular
Apr 2024
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K240397 is an FDA 510(k) clearance for the AlphaVac MMA F1885 System (H787253020), a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on April 1, 2024, 52 days after receiving the submission on February 9, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K240397 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2024
Decision Date April 01, 2024
Days to Decision 52 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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