Aveir Retrieval Catheter— 510(k) K213494

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K213494 for Aveir Retrieval Catheter, Substantially Equivalent on 2022-04-01. Applicant: ABBOTT MEDICAL.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code MMX
Advisory panel: Cardiovascular
Date received: 2021-11-01
Decision date: 2022-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

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.