Prelude SNAP Splittable Sheath Introducer

Prelude SNAP Splittable Sheath Introducer is an FDA 510(k)-cleared medical device (K143255) 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 April 8, 2015. Regulation: 8.