# K983819: Intergard Knitted Ultra Thin Collagen Coated Vascular Graft and Hemacarotid Patch Ultra Thin

- Pathway: 510(k) (Special)
- Applicant: Intervascular, Inc.
- Decided: Nov 24, 1998 after 26 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Dec 30, 2003 · Not classified · Z-0638-04: Water permeability of the patch is out of specification.

## Indications for use
InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the 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. The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.

Source page: https://510kreport.com/device/K983819
Methodology: https://510kreport.com/methodology