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FDA 510(k) Applications Submitted by BIOCARDIA, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K012749
08/16/2001
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
BIOCARDIA, INC.
K042553
09/20/2004
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
BIOCARDIA, INC.
K090999
04/08/2009
BIOCARDIA MORPH SHEATH GUIDE
BIOCARDIA, INC.
K190941
04/10/2019
BioCardia 8.5 F Avance Steerable lntroducer
BioCardia, Inc.
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