Reprocessed PentaRay Nav eco High-Density Mapping Catheter

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is an FDA 510(k)-cleared medical device (K201806) manufactured by Sterilmed Inc. (Johnson and Johnson). 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 22, 2021. Regulation: 8.