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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
Applicant
BIOCARDIA, INC.
125 SHOREWAY ROAD, SUITE B
SAN CARLOS,  CA  94070
Applicant Contact DAVID SNOW
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN SIMON CHRISTENSEN
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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