# K990800: Intergard Knitted Ultra Thin and Intergard Knitted Collagen Coated and Heparin Bonded Vascular Prothesis

- Pathway: 510(k) (Traditional)
- Applicant: Intervascular, Inc.
- Decided: Jan 8, 2001 after 670 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 its predicate without a number.
- (no number) InterGard Knitted Collagen Coated Vascular Prostheses: named in the summary without a submission number
- (no number) InterGard Knitted Ultra-Thin Collagen Coated Vascular Prostheses: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K990800
Methodology: https://510kreport.com/methodology