Endophys Pressure Sensing Sheath Kit- 8F

Endophys Pressure Sensing Sheath Kit- 8F is an FDA 510(k)-cleared medical device (K173399) 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 November 29, 2017. Regulation: 8.