CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING— 510(k) K113667

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K113667 for CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING, Substantially Equivalent on 2012-01-12. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2011-12-13
Decision date: 2012-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Draper, UT, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.