# K984182: Perma-Pass Vascular Graft, 6S Graft,Model 31453, 6T Graft,Model 31452

- Pathway: 510(k) (Traditional)
- Applicant: Possis Medical, Inc.
- Decided: Feb 1, 1999 after 70 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 K791810 (1979). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791810: Vascular Graft Prost. of Expanded Ptfe, Impra, Inc. (1979) Summary page 1.

## Indications for use
The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only. Thinwall Perma-Pass Grafts are not indicated for blood access. Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava.

Source page: https://510kreport.com/device/K984182
Methodology: https://510kreport.com/methodology