FOGARTY OCCLUSION CATHETER— 510(k) K093911

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K093911 for FOGARTY OCCLUSION CATHETER, Substantially Equivalent on 2010-01-21. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2009-12-22
Decision date: 2010-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.