Fogarty Thru-Lumen Embolectomy Catheter— 510(k) K240078

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K240078 for Fogarty Thru-Lumen Embolectomy Catheter, Substantially Equivalent on 2024-08-28. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 2024-01-11
Decision date: 2024-08-28
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.