# K991137: Enguard PHX Cardioplegia Heat Exchanger

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Jun 8, 2000 after 430 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: 2 generations back to K896807 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960755: Cardiotherm Blood Cardioplegia Systems, Medtronic Cardiac Surgery, Medtronic, Inc. (1996) Summary page 2.
- K925369: BCD Advanced Blood Carioplegia Systems, Sorin Biomedica, Fiat, USA, Inc. (1993) Summary page 2.
- K904171: Scimed Cardiotherm Cardioplegia Delivery System, Scimed (1990) Summary page 2.

## Indications for use
The Minntech Corporation’s EnGuard™ Cardioplegia Heat Exchanger is used to cool or warm cardioplegia solution prior to delivery to the patient through connected tubing sets which provide various ratios of cardioplegia solution to blood, depending upon the tubing set chosen.

Source page: https://510kreport.com/device/K991137
Methodology: https://510kreport.com/methodology