FlexSeal Introducer Sheath with Hydrophilic Coating

FlexSeal Introducer Sheath with Hydrophilic Coating is an FDA 510(k)-cleared medical device (K190628) manufactured by Freudenberg Medical Mis, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2019. Regulation: 8.