510(k) K260105— Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

Substantially Equivalent

Edwards Lifesciences

Clearance details

Applicant: Edwards Lifesciences
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2026-01-13
Decision date: 2026-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.