# K981076: Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Impra, Inc.
- Decided: May 7, 1998 after 44 days
- Product code: DYF (Prosthesis, Vascular Graft, Of Less Then 6mm 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) Venaflo ePTFE Vascular Graft: named in the summary without a submission number
- (no number) IMPRA Carboflo Vascular Graft: named in the summary without a submission number

## Indications for use
The Venaflo Grafts with Carbon are indicated for subcutaneous arteriovenous conduit for blood access only.

Source page: https://510kreport.com/device/K981076
Methodology: https://510kreport.com/methodology