# K012898: Modification to: CSC14 Blood Cardioplegia System

- Pathway: 510(k) (Special)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Sep 17, 2001 after 19 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: 1 generation back to K934847 (1994). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934847: Ngbcd & Ngbcdp Cardioplegia Delivery Systems, Sorin Biomedical, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K223879: Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (2023), 0 descendants of its own

## Indications for use
The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump through the extension line and appropriate cannula.

Source page: https://510kreport.com/device/K012898
Methodology: https://510kreport.com/methodology