# K013393: Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1H

- Pathway: 510(k) (Special)
- Applicant: A-Med Systems, Inc.
- Decided: Nov 9, 2001 after 25 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
Longest line of descent: 3 generations back to K852698 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992592: A-Miniature Centrifugal Blood Pump System, Model CPB 2000, A-Med Systems, Inc. (2000) Summary page 1.

## Indications for use
The A-Med Heparin Coated Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

Source page: https://510kreport.com/device/K013393
Methodology: https://510kreport.com/methodology