# K955588: Vascutek Graft Sizer Set

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Mar 7, 1996 after 91 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 K854431 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854431: Meadox Medicals Inc. Graft Sizer, Meadox Medicals, Div. Boston Scientific Corp. (1986) Summary page 1.

## Indications for use
The Vascutek Graft Sizer Set is designed to aid the surgeon in accurately matching the size of vascular graft to the artery. The size of graft to be selected will correspond with the number indicated on the graft sizer which best fits the outside of the vessel.

Source page: https://510kreport.com/device/K955588
Methodology: https://510kreport.com/methodology