EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700— 510(k) K082139

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K082139 for EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700, Substantially Equivalent on 2008-10-23. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 2008-07-29
Decision date: 2008-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.