
Medical Device Technologies, Inc.
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MANAN(TM) INTRODUCER SHEATH/NEEDLE is an FDA 510(k)-cleared medical device (K974815) manufactured by Medical Device Technologies, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 8, 1998. Regulation: 8.