# K162579: VascuCel

- Pathway: 510(k) (Special)
- Applicant: Admedus Regen Pty, Ltd.
- Decided: Oct 14, 2016 after 29 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: 6 generations back to K842066 (1985). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 17 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.

## Most influential descendants
- K200566: ADAPT Tissue (2020), 0 descendants of its own

## Indications for use
VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.

Source page: https://510kreport.com/device/K162579
Methodology: https://510kreport.com/methodology