Prelude IDeal Hydrophilic Sheath Introducer

Prelude IDeal Hydrophilic Sheath Introducer is an FDA 510(k)-cleared medical device (K173750) manufactured by Merit Medical Systems, 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 February 14, 2018. Regulation: 8.