# K032125: Cstat, Models 09-0014-01 and 09-0014-02

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Control Systems, Inc.
- Decided: Feb 9, 2004 after 214 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: 3 generations back to K935994 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023154: VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02, Vascular Control Systems, Inc. (2002) Summary page 1.
- K023024: Transvaginal Doppler Probe, Model 09-0006-02, Vascular Control Systems, Inc. (2002) Summary page 1.
- K022712: Hand Drill, Model 11-9901-7, Medical Design, LLC (2002) Summary page 1.

## Indications for use
The Cstat is intended for detection and temporary occlusion of blood vessels during vascular surgical procedures.

Source page: https://510kreport.com/device/K032125
Methodology: https://510kreport.com/methodology