# K233976: VasoGuard (V10, V8, V6, V4, V2)

- Pathway: 510(k) (Traditional)
- Applicant: Corvascular Diagnostics, LLC
- Decided: Jul 19, 2024 after 217 days
- Product code: JOP (Transducer, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 870.2880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904392 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111416: Falcon, Viasonix, Ltd. (2011) Summary page 4.

## Indications for use
The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use by qualified and trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.

Source page: https://510kreport.com/device/K233976
Methodology: https://510kreport.com/methodology