AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System— 510(k) K213388

Substantially Equivalent

AngioDynamics, Inc.

FDA 510(k) clearance K213388 for AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System, Substantially Equivalent on 2022-04-04. Applicant: AngioDynamics, Inc..

Clearance details

Applicant: AngioDynamics, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2021-10-14
Decision date: 2022-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Queensburgy, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.