K-number	K190941
Device name	BioCardia 8.5 F Avance Steerable lntroducer
Applicant	Biocardia, Inc.
Product code	DYB
Device class	Class II
Decision date	May 6, 2019
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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BioCardia 8.5 F Avance Steerable lntroducer

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