# K960755: Cardiotherm Blood Cardioplegia Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Cardiac Surgery, Medtronic, Inc.
- Decided: May 23, 1996 after 90 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K896807 (1990). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934355: Electromedics Blood Heat Exchanger, Electromedics, Inc. (1993) Summary page 1.
- K896807: SPBC Series Single Pass Blood Cardioplegia System, Gish Biomedical, Inc. (1990) Summary page 1.
- K944219: Single Pass  Blood Cardioplegia SPBC System Components, Gish Biomedical, Inc. (1995) Summary page 1.
- K904171: Scimed Cardiotherm Cardioplegia Delivery System, Scimed (1990) Summary page 1.
- K925369: BCD Advanced Blood Carioplegia Systems, Sorin Biomedica, Fiat, USA, Inc. (1993) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

Source page: https://510kreport.com/device/K960755
Methodology: https://510kreport.com/methodology