Biocardia, Inc. is one of 26017 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biocardia, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BioCardia 8.5 F Avance Steerable lntroducer, BIOCARDIA MORPH SHEATH GUIDE, BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
4
Total
4
Cleared
0
Denied
Biocardia, Inc. has 4 FDA 510(k) cleared medical devices. Based in South San Francisco, US.
Historical record: 4 cleared submissions from 2002 to 2019. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Biocardia, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Underwriters Laboratories, Inc. and Regulatory Technology Services, LLC.
FDA 510(k) Regulatory Record - Biocardia, Inc.
4 devices
Cleared
May 06, 2019
BioCardia 8.5 F Avance Steerable lntroducer
Cardiovascular
26d
Cleared
Apr 15, 2009
BIOCARDIA MORPH SHEATH GUIDE
Cardiovascular
7d
Cleared
Feb 17, 2005
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
Cardiovascular
150d
Cleared
Jan 24, 2002
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
Cardiovascular
161d