IntellaMap Orion High Resolution Mapping Catheter

IntellaMap Orion High Resolution Mapping Catheter is an FDA 510(k)-cleared medical device (K220796) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 2022. Regulation: 8.