# K962320: S3 Cardioplegia Control

- Pathway: 510(k) (Traditional)
- Applicant: Stoeckert Instrumente
- Decided: Jan 10, 1997 after 207 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stockert CAPS Cardioplegia Control unit: named in the summary without a submission number

## Indications for use
The Stockert S3 Cardioplegia Control Module is an accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System, and is intended to control and monitor the use of cardioplegia solutions during the bypass procedure.

Source page: https://510kreport.com/device/K962320
Methodology: https://510kreport.com/methodology