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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K090999
Device Name BIOCARDIA MORPH SHEATH GUIDE
Original Applicant
BIOCARDIA, INC.
125 shoreway road, suite b
san carlos,  CA  94070
Original Contact david snow
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/08/2009
Decision Date 04/15/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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