# K071140: Mri Compatible Thigh Tourniquet, Model C070002

- Pathway: 510(k) (Traditional)
- Applicant: Top Spins, Inc.
- Decided: Jun 7, 2007 after 44 days
- Product code: KCY (Tourniquet, Pneumatic)
- Device class: 1
- Regulation: 21 CFR 878.5910
- 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
This device is intended for use in MR imaging of peripheral blood vessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.

Source page: https://510kreport.com/device/K071140
Methodology: https://510kreport.com/methodology