# K130872: Cardiocel

- Pathway: 510(k) (Traditional)
- Applicant: Celxcel Pty, Ltd.
- Decided: Jan 30, 2014 after 307 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: 5 generations back to K842066 (1985). 14 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082139: Edwards Bovine Pericardial Patch, Model 4700, Edwards Lifesciences, LLC (2008) Summary page 1.
- K971726: CV Peri-Guard - Cardiovascular Patch, Bio-Vascular, Inc. (1998) Summary page 1.

## Most influential descendants
- K162579: VascuCel (2016), 1 descendant of its own
- K200566: ADAPT Tissue (2020), 0 descendants of its own
- K170951: CardioCel 3D (2017), 0 descendants of its own

## Indications for use
CardioCel 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/K130872
Methodology: https://510kreport.com/methodology