# K103347: Cardioroot Woven Collagen Coated Vascular Prostheses

- Pathway: 510(k) (Special)
- Applicant: Intervascular Sas
- Decided: Feb 2, 2011 after 79 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. The FDA summary names no predicate by number.

## Recalls of this device
- Aug 12, 2026 · Class II · Z-3258-2026: Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

## Indications for use
Woven Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive diseases of the aorta, both thoracic and abdominal, visceral arteries, and proximal peripheral arteries. Due to the low porosity of Woven vascular grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

Source page: https://510kreport.com/device/K103347
Methodology: https://510kreport.com/methodology