# K180957: exGraft, exGraft Carbon ePTFE Vascular Grafts

- Pathway: 510(k) (Traditional)
- Applicant: Peca Labs
- Decided: Aug 21, 2018 after 131 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: 1 generation back to K954582 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004011: Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V Access, Impra, Inc. (2001) Summary page 4.
- K954582: Bard Expanded Ptfe Vascular Graft (Modification), C.R. Bard, Inc. (1995) Summary page 4.

## Indications for use
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.

Source page: https://510kreport.com/device/K180957
Methodology: https://510kreport.com/methodology