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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K072297
Device Name BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
Applicant
Cardiva Medical, Inc.
155 Moffett Park Dr.,
Suite A-210
Sunnyvale,  CA  94089
Applicant Contact KIT CARIQUITAN
Correspondent
Cardiva Medical, Inc.
155 Moffett Park Dr.,
Suite A-210
Sunnyvale,  CA  94089
Correspondent Contact KIT CARIQUITAN
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/17/2007
Decision Date 09/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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