# K023427: Cardiassist Counterpulsation System, Model Mark 3000

- Pathway: 510(k) (Traditional)
- Applicant: Cardiomedics, Inc.
- Decided: Jan 7, 2003 after 88 days
- Product code: DRN (Device, Counter-Pulsating, External)
- Device class: 2
- Regulation: 21 CFR 870.5225
- 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 K940264 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022107: Cardiassist Counterpulsation System, Model Mark 3000, Cardiomedics, Inc. (2002)
- K020857: Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter, Vasomedical, Inc. (2002)

## Most influential descendants
- K050172: Cardiassist Counter Pulsation System Series 4000/5000 (2005), 0 descendants of its own

## Indications for use
The CardioMedics, Inc., CardiAssistTM CounterPulsation System is intended to provide external counterpulsation (ECP) by increasing perfusion during diastole for the treatment of angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock and may enhance coronary function.

Source page: https://510kreport.com/device/K023427
Methodology: https://510kreport.com/methodology