# K230248: VIOLA

- Pathway: 510(k) (Special)
- Applicant: Vascular Graft Solutions, Ltd.
- Decided: Feb 28, 2023 after 29 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: 6 generations back to K800122 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203307: VIOLA, Vascular Graft Solutions, Ltd. (2021) Summary page 4.

## Indications for use
VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

Source page: https://510kreport.com/device/K230248
Methodology: https://510kreport.com/methodology