# K240775: PeriBeam®  Pericardial Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Tamabio
- Decided: Apr 18, 2025 after 393 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012098 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012098: Preclude Pericardial Membrane, W. L. Gore & Associates, Inc. (2001) Summary page 5.

## Indications for use
The PeriBeam® Pericardial Membrane is indicated for the reconstruction or repair of the pericardium.

Source page: https://510kreport.com/device/K240775
Methodology: https://510kreport.com/methodology