K192615

Substantially Equivalent

Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)

Applicant: Synovis Life Technologies, Inc. (Baxter International Inc.)
Product code: FTM
Advisory panel: General, Plastic Surgery
Date received: 2019-09-23
Decision date: 2019-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.