OPTRELL™ Mapping Catheter with TRUEref™ Technology

OPTRELL™ Mapping Catheter with TRUEref™ Technology is an FDA 510(k)-cleared medical device (K230253) manufactured by Biosense Webster, 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 March 1, 2023. Regulation: 8.