GORE TRI-LOBE BALLOON CATHETER— 510(k) K081799

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K081799 for GORE TRI-LOBE BALLOON CATHETER, Substantially Equivalent on 2008-10-03. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2008-06-25
Decision date: 2008-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.