# K092863: Maxiflo, Taperflo

- Pathway: 510(k) (Special)
- Applicant: Vascutek, Ltd.
- Decided: Oct 8, 2009 after 21 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Creation of subcutaneous arteriovenous conduits for blood access, bypass or reconstruction of occluded or diseased arterial blood vessels.

Source page: https://510kreport.com/device/K092863
Methodology: https://510kreport.com/methodology