Reprocessed DecaNav Diagnostic Electrophysiology Catheter

Reprocessed DecaNav Diagnostic Electrophysiology Catheter is an FDA 510(k)-cleared medical device (K180710) 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 June 18, 2018. Regulation: 8.