ViaCath, AcQRate Dx Steerable Catheter

ViaCath, AcQRate Dx Steerable Catheter is an FDA 510(k)-cleared medical device (K212593) manufactured by Biotronick, 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 October 14, 2021. Regulation: 8.