K-number	K192774
Device name	BioCardia 8F Morph DNA Deflectable Guide Catheter
Applicant	Biocardia
Product code	DQY
Device class	Class II
Decision date	Jan 7, 2020
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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BioCardia 8F Morph DNA Deflectable Guide Catheter

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