Bovine Pericardial Tissue Patch— 510(k) K182493

Substantially Equivalent

Tisgenx

FDA 510(k) clearance K182493 for Bovine Pericardial Tissue Patch, Substantially Equivalent on 2019-06-18. Applicant: Tisgenx.

Clearance details

Applicant: Tisgenx
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2018-09-11
Decision date: 2019-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.