Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is an FDA 510(k)-cleared medical device (K190980) 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 30, 2019. Regulation: 8.