PRECLUDE PERICARDIAL MEMBRANE— 510(k) K012098

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K012098 for PRECLUDE PERICARDIAL MEMBRANE, Substantially Equivalent on 2001-09-20. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 2001-07-05
Decision date: 2001-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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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.