GORE-TEX VASULAR GRAFT— 510(k) K811510

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K811510 for GORE-TEX VASULAR GRAFT, Substantially Equivalent on 1981-08-20. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1981-05-27
Decision date: 1981-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.