# K030532: CPCA2000 Counterpulsation System

- Pathway: 510(k) (Traditional)
- Applicant: Cpca2000, Inc.
- Decided: Mar 14, 2003 after 23 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: 1 generation back to K940264 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940264: Vasogenics Eecp-MC2, Vasogenics, Inc. (1995) Summary page 1.

## Indications for use
The CPCA2000TMCounterpulsation System is a non-invasive external counterpulsation device intended for use in the treatment of patients with stable or unstable angina pectoris, congestive heart failure, acute myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.

Source page: https://510kreport.com/device/K030532
Methodology: https://510kreport.com/methodology