# K052282: Venaflo II Vascular Graft

- Pathway: 510(k) (Special)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Sep 20, 2005 after 29 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 K981079 (1998). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981079: Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft, Impra, Inc. (1998) Summary page 1.

## Most influential descendants
- K094044: Spiral Laminar Flow Vascular Arteriovenous Graft (2010), 1 descendant of its own
- K252277: Spiral Laminar Flow™ Vascular Arteriovenous Graft  (AV0645) (2025), 0 descendants of its own

## Indications for use
Venaflo TM II Vascular Grafts are indicated for use as subcutaneous arteriovenous conduits for blood access only.

Source page: https://510kreport.com/device/K052282
Methodology: https://510kreport.com/methodology