GORE FLOW REVERSAL SYSTEM— 510(k) K083300

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K083300 for GORE FLOW REVERSAL SYSTEM, Substantially Equivalent on 2009-02-04. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2008-11-10
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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Adverse events under product code NTE

product code NTE

Death: 28
Injury: 1,348
Malfunction: 771
Total: 2,147

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.