SPREADABLE SHEATH INTRODUCER SET

SPREADABLE SHEATH INTRODUCER SET is an FDA 510(k)-cleared medical device (K960625) manufactured by Neostar Medical Technologies, 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 August 7, 1996. Regulation: 8.