CARDIOMEDICS ECP SYSTEM— 510(k) K010261

Substantially Equivalent

Cardiomedics, Inc.

FDA 510(k) clearance K010261 for CARDIOMEDICS ECP SYSTEM, Substantially Equivalent on 2001-02-28. Applicant: Cardiomedics, Inc.. Device class: 2.

Clearance details

Applicant: Cardiomedics, Inc.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2001-01-29
Decision date: 2001-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRN

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

More clearances from Cardiomedics, Inc.

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