# K934763: Sorin Blood Cardioplegia System

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Biomedical, Inc.
- Decided: Apr 15, 1994 after 192 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020106: Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger (2002), 2 descendants of its own
- 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) (2025), 0 descendants of its own
- K081838: Gish Vision Blood Cardioplegia with HA Coating (2009), 0 descendants of its own
- K040355: Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K934763
Methodology: https://510kreport.com/methodology