BioCardia 8F Morph DNA Deflectable Guide Catheter

BioCardia 8F Morph DNA Deflectable Guide Catheter is an FDA 510(k)-cleared medical device (K192774) manufactured by Biocardia. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2020. Regulation: 8.