510(k) K192774

BioCardia 8F Morph DNA Deflectable Guide Catheter by Biocardia — Product Code DQY

K192774 is an FDA 510(k) premarket notification submitted by Biocardia for the device "BioCardia 8F Morph DNA Deflectable Guide Catheter". The FDA issued a decision of Substantially Equivalent on January 7, 2020. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Biocardia has at least 5 other 510(k) clearances on record.