# K964017: Affinity Blood Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Avecor Cardiovascular, Inc.
- Decided: Aug 5, 1997 after 302 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- 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 Instrumente (Sorin) Blood Pump System: named in the summary without a submission number

## Indications for use
The Affinity™ Blood Pump System is intended to be used in an extracorporeal perfusion circuit to pump blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Source page: https://510kreport.com/device/K964017
Methodology: https://510kreport.com/methodology