BioCardia 8.5 F Avance Steerable lntroducer

BioCardia 8.5 F Avance Steerable lntroducer is an FDA 510(k)-cleared medical device (K190941) manufactured by Biocardia, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 2019. Regulation: 8.