GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE— 510(k) K914448

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K914448 for GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE, Substantially Equivalent on 1991-11-05. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1991-10-04
Decision date: 1991-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.