HeartSpan Steerable Sheath Introducer

HeartSpan Steerable Sheath Introducer is an FDA 510(k)-cleared medical device (K170668) 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 4, 2017. Regulation: 8.