Reprocessed Inquiry Steerable Diagnostic EP Catheter

Reprocessed Inquiry Steerable Diagnostic EP Catheter is an FDA 510(k)-cleared medical device (K203261) 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 March 4, 2021. Regulation: 8.