# K221628: exGraft, exGraft Carbon

- Pathway: 510(k) (Traditional)
- Applicant: Peca Labs
- Decided: Aug 4, 2022 after 59 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K013250 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202471: exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft, Peca Labs (2020) Summary page 4.

## Most influential descendants
- K233783: exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (2024), 0 descendants of its own

## Indications for use
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures,

Source page: https://510kreport.com/device/K221628
Methodology: https://510kreport.com/methodology