PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER is an FDA 510(k)-cleared medical device (K120425) 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 May 23, 2012. Regulation: 8.