# K170951: CardioCel 3D

- Pathway: 510(k) (Special)
- Applicant: Admedus Regen Pty, Ltd.
- Decided: Apr 28, 2017 after 28 days
- Product code: PSQ (Intracardiac Patch Or Pledget, Biologically Derived)
- 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: 6 generations back to K842066 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130872: Cardiocel, Celxcel Pty, Ltd. (2014) Summary page 4.

## Indications for use
CardioCel 3D is indicated for use as a patch in pericardial closure and the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.

Source page: https://510kreport.com/device/K170951
Methodology: https://510kreport.com/methodology