OPTRELL Mapping Catheter with TRUEref Technology

OPTRELL Mapping Catheter with TRUEref Technology is an FDA 510(k)-cleared medical device (K211438) 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 17, 2022. Regulation: 8.