510(k) K211081— AlphaVac Multipurpose Mechanical Aspiration (MMA) System

Substantially Equivalent

AngioDynamics, Inc.

Clearance details

Applicant: AngioDynamics, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2021-04-12
Decision date: 2021-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Queensburgy, NY, US

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.