DISPOSABLE PEEL-AWAY INTRODUCER SHEATH

DISPOSABLE PEEL-AWAY INTRODUCER SHEATH is an FDA 510(k)-cleared medical device (K931973) manufactured by Neuro Navigational Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 1993. Regulation: 8.