AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED— 510(k) K941981

Substantially Equivalent - Subject to Tracking & PMS

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K941981 for AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED, Substantially Equivalent - Subject to Tracking & PMS on 1994-07-20. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1994-04-14
Decision date: 1994-07-20
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Flagstaff, AZ, 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.