K141206

Substantially Equivalent

EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM

Applicant: Edwards Lifesciences, LLC
Product code: GAW
Advisory panel: General, Plastic Surgery
Date received: 2014-05-09
Decision date: 2015-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.