Endophys Pressure Sensing Sheath Kit

Endophys Pressure Sensing Sheath Kit is an FDA 510(k)-cleared medical device (K180620) manufactured by Endophys Holdings, 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 October 11, 2018. Regulation: 8.