GORE(R) EMBOLIC FILTER— 510(k) K120480

Substantially Equivalent

W.L. Gore & Associates

FDA 510(k) clearance K120480 for GORE(R) EMBOLIC FILTER, Substantially Equivalent on 2012-03-16. Applicant: W.L. Gore & Associates.

Clearance details

Applicant: W.L. Gore & Associates
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2012-02-16
Decision date: 2012-03-16
Decision: Substantially Equivalent
Clearance type: Special
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.