# K222297: CentriMag Pre-connected Pack

- Pathway: 510(k) (Traditional)
- Applicant: Abbott
- Decided: Dec 1, 2022 after 122 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K932252 (1993). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200109: OXY-1 System, Abiomed, Inc. (2020) Summary page 5.

## Indications for use
The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Source page: https://510kreport.com/device/K222297
Methodology: https://510kreport.com/methodology