# K250150: VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: May 30, 2025 after 129 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- 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 K934763 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934763: Sorin Blood Cardioplegia System, Sorin Biomedical, Inc. (1994) Summary page 6.
- K934847: Ngbcd & Ngbcdp Cardioplegia Delivery Systems, Sorin Biomedical, Inc. (1994) Summary page 6.

## Indications for use
Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.

Source page: https://510kreport.com/device/K250150
Methodology: https://510kreport.com/methodology