# K944219: Single Pass  Blood Cardioplegia SPBC System Components

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Jun 30, 1995 after 305 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
No predicates in its family tree.
4 later devices descend from it; 1 cites 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960755: Cardiotherm Blood Cardioplegia Systems (1996), 3 descendants of its own
- K991137: Enguard PHX Cardioplegia Heat Exchanger (2000), 0 descendants of its own
- K973237: CSS-Cardioplegia Safety System (1998), 0 descendants of its own
- K973475: Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series) (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K944219
Methodology: https://510kreport.com/methodology