
Smiths Medical MD, Inc.
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SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS is an FDA 510(k)-cleared medical device (K112407) manufactured by Smiths Medical MD, 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 8, 2012. Regulation: 8.