Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe— 510(k) K193379

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K193379 for Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe, Substantially Equivalent on 2020-06-12. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 2019-12-05
Decision date: 2020-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.