CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000— 510(k) K050172

Name: FDA 510(k) clearance K050172
Creator: U.S. Food and Drug Administration
Published: 2005-03-31

Substantially Equivalent

Cardiomedics, Inc.

FDA 510(k) clearance K050172 for CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000, Substantially Equivalent on 2005-03-31. 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: 2005-01-26
Decision date: 2005-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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