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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K050172
Device Name CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
Applicant
Cardiomedics, Inc.
18872 Bardeen Ave.
Irvine,  CA  92612
Applicant Contact JOHN HUTCHINS
Correspondent
Cardiomedics, Inc.
18872 Bardeen Ave.
Irvine,  CA  92612
Correspondent Contact JOHN HUTCHINS
Regulation Number870.5225
Classification Product Code
DRN  
Date Received01/26/2005
Decision Date 03/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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