DURA-GUARD-DURAL REPAIR PATCH— 510(k) K973706

Substantially Equivalent

Bio-Vascular, Inc.

FDA 510(k) clearance K973706 for DURA-GUARD-DURAL REPAIR PATCH, Substantially Equivalent on 1997-12-24. Applicant: Bio-Vascular, Inc..

Clearance details

Applicant: Bio-Vascular, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 1997-09-29
Decision date: 1997-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

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.