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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 K061075
Device Name BOOMERANG WIRE
Applicant
Cardiva Medical, Inc.
2585 Leghorn St.
Moutian View,  CA  94043
Applicant Contact GLENN FOY
Correspondent
Cardiva Medical, Inc.
2585 Leghorn St.
Moutian View,  CA  94043
Correspondent Contact GLENN FOY
Regulation Number870.4450
Classification Product Code
DXC  
Date Received04/17/2006
Decision Date 09/01/2006
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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