# K970843: Intergard Woven Collagen Coated Vascular Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Intervascular, Inc.
- Decided: Jun 5, 1997 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
InterGard woven vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

Source page: https://510kreport.com/device/K970843
Methodology: https://510kreport.com/methodology