# K233783: exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

- Pathway: 510(k) (Traditional)
- Applicant: Peca Labs, Inc.
- Decided: Jan 17, 2024 after 51 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: 3 generations back to K013250 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221628: exGraft, exGraft Carbon, Peca Labs (2022) Summary page 4.

## 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/K233783
Methodology: https://510kreport.com/methodology