Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is an FDA 510(k)-cleared medical device (K191880) 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 December 10, 2019. Regulation: 8.