# K973237: CSS-Cardioplegia Safety System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Bio-Medicus, Inc.
- Decided: Apr 27, 1998 after 242 days
- Product code: DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4370
- 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 K802147 (1980). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942582: Sorin Blood Cardioplegia Console, Sorin Biomedical, Inc. (1995) Summary page 1.
- K953838: Myocardial Protection System, Quest Medical, Inc. (1996) Summary page 1.
- K871131: Sarns 9000 Heart-Lung Console, 3M Health Care, Sarns (1987) Summary page 1.
- K960755: Cardiotherm Blood Cardioplegia Systems, Medtronic Cardiac Surgery, Medtronic, Inc. (1996) Summary page 1.

## Indications for use
The Medltronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous cardioplegia solution during cardiopulmonary bypass procedures.

Source page: https://510kreport.com/device/K973237
Methodology: https://510kreport.com/methodology