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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K070051
Device Name ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
Applicant
ACUMEN MEDICAL, INC.
275 SANTA ANA COURT
SUNNYVALE,  CA  94085
Applicant Contact Marybeth Gamber
Correspondent
ACUMEN MEDICAL, INC.
275 SANTA ANA COURT
SUNNYVALE,  CA  94085
Correspondent Contact Marybeth Gamber
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/04/2007
Decision Date 04/06/2007
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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