# K201068: Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 21, 2020 after 29 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Affinity CP centrifugal blood pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). The Affinity CP centrifugal blood pump is driven by the external drive motor or the emergency handcrank. The Affinity CP centrifugal blood pump is intended for use with pump speed controllers approved by Medtronic or may be used with the Stockert and Sorin centrifugal pump systems or the Sarns and Terumo centrifugal systems by attaching the Affinity CP adapter. The Affinity CP centrifugal blood pump with Balance biosurface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). The Affinity CP centrifugal blood pump with Balance biosurface is driven by the external drive motor or the emergency handcrank. The Affinity CP centrifugal blood pump with Balance biosurface is intended for use with pump speed controllers approved by Medtronic or may be used with the Stockert and Sorin centrifugal pump systems or the Sarns and Terumo centrifugal systems by attaching the Affinity CP adapter. The Affinity CP centrifugal blood pump with Cortiva BioActive Surface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). The Affinity CP centrifugal blood pump with Cortiva BioActive Surface is driven by the external drive motor or the emergency handcrank. The Affinity CP centrifugal blood pump with Cortiva BioActive Surface is intended for use with pump speed controllers approved by Medtronic or may be used with the Stockert and Sorin centrifugal pump systems or the Sarns and Terumo centrifugal systems by attaching the Affinity CP adapter.

Source page: https://510kreport.com/device/K201068
Methodology: https://510kreport.com/methodology