Reprocessed IntellaMap Orion High Resolution Mapping Catheter

Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an FDA 510(k)-cleared medical device (K211662) manufactured by Innovative Health, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2021. Regulation: 8.