Reprocessed Marinr Diagnostic EP Catheter

Reprocessed Marinr Diagnostic EP Catheter is an FDA 510(k)-cleared medical device (K181897) 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 14, 2018. Regulation: 8.