Prelude IDeal 9F Hydrophilic Sheath Introducer

Prelude IDeal 9F Hydrophilic Sheath Introducer is an FDA 510(k)-cleared medical device (K212152) manufactured by Merit Medical Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2022. Regulation: 8.