# K934847: Ngbcd & Ngbcdp Cardioplegia Delivery Systems

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Biomedical, Inc.
- Decided: Apr 15, 1994 after 189 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 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
- K012898: Modification to: CSC14 Blood Cardioplegia System (2001), 6 descendants of its own
- K212688: Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (2022), 2 descendants of its own
- K072583: Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30 (2008), 2 descendants of its own
- K220110: Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger (2022), 1 descendant of its own
- K090555: Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30 (2009), 1 descendant of its own

## Recalls of this device
- May 25, 2004 · Not classified · Z-1009-04: Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
- May 9, 2003 · Not classified · Z-0960-03: Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.

Source page: https://510kreport.com/device/K934847
Methodology: https://510kreport.com/methodology