Reprocessed Orbiter ST Steerable Diagnostic EP Catheter

Reprocessed Orbiter ST Steerable Diagnostic EP Catheter is an FDA 510(k)-cleared medical device (K161393) 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 October 25, 2016. Regulation: 8.