GORE® ACUSEAL Vascular Graft— 510(k) K231505

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K231505 for GORE® ACUSEAL Vascular Graft, Substantially Equivalent on 2023-06-23. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2023-05-24
Decision date: 2023-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

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.