# K070323: Temporary Limb Salvage Shunt

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Feb 15, 2007 after 13 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K992832 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062474: Smithwick Carotid Shunt, Mcpherson Enterprises, Inc. (2006) Summary page 1.
- K052302: Hemashield Platinum Woven Double Velour Taaa Graft Configuration, Boston Scientific Corp (2005) Summary page 1.
- K021213: Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts, Boston Scientific Corp (2002) Summary page 1.
- K992832: Sulzer Vascutek Eptfe Vascular Prosthesis, Sulzermedica (1999) Summary page 1.

## Indications for use
THIS DEVICE IS INTENDED TO BE USED AS A TEMPORARY BYPASS SHUNT IN LIMB THREATENING TRAUMA CASES WHERE THERE HAS BEEN DAMAGE TO A MAJOR BLOOD VESSEL

Source page: https://510kreport.com/device/K070323
Methodology: https://510kreport.com/methodology