# K141721: Bovine Pericardium Patch

- Pathway: 510(k) (Traditional)
- Applicant: Collafirm, LLC
- Decided: Dec 22, 2014 after 180 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K842066 (1985). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062915: Veritas Collagen Matrix, Synovis Surgical Innovations (2006) Summary page 4.

## Indications for use
Bovine Pericardium Patch is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following: Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excision of the lung and bronchus. Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).

Source page: https://510kreport.com/device/K141721
Methodology: https://510kreport.com/methodology