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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 K082930
Device Name CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
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 Received10/01/2008
Decision Date 02/13/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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