Endophys Pressure Sensing Sheath

Endophys Pressure Sensing Sheath is an FDA 510(k)-cleared medical device (K190098) 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 March 6, 2019. Regulation: 8.