Reprocessed PentaRay Nav eco High-Density Mapping Catheter

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is an FDA 510(k)-cleared medical device (K190785) 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 24, 2019. Regulation: 8.