TISSUE PATCH, TISSUE GRAFT— 510(k) K921895

Unknown

Bio-Vascular, Inc.

FDA 510(k) clearance K921895 for TISSUE PATCH, TISSUE GRAFT, Unknown on 1992-11-04. Applicant: Bio-Vascular, Inc..

Clearance details

Applicant: Bio-Vascular, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1992-04-22
Decision date: 1992-11-04
Decision: Unknown
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.