CPCA2000 COUNTERPULSATION SYSTEM— 510(k) K030532

Name: FDA 510(k) clearance K030532
Creator: U.S. Food and Drug Administration
Published: 2003-03-14

Substantially Equivalent

Cpca2000, Inc.

FDA 510(k) clearance K030532 for CPCA2000 COUNTERPULSATION SYSTEM, Substantially Equivalent on 2003-03-14. Applicant: Cpca2000, Inc.. Device class: 2.

Clearance details

Applicant: Cpca2000, Inc.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2003-02-19
Decision date: 2003-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRN

view all

K250756 — Pression Wave PRO External Counter-Pulsation System2025-12-22
K202108 — External Counterpulsation System, Soulaire2020-08-28
K191955 — Enhanced External Counter Pulsation Device Plus Omay-A2020-08-05
K190683 — External Counterpulsation System2019-09-10
K173483 — Pure Flow External Counter-Pulsation Device2018-05-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.