K012098

Substantially Equivalent

PRECLUDE PERICARDIAL MEMBRANE

Applicant: W. L. Gore & Associates, Inc.
Product 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

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.