RAPID-TRAK(TM) INTRODUCER SHEATH

RAPID-TRAK(TM) INTRODUCER SHEATH is an FDA 510(k)-cleared medical device (K950155) manufactured by Cardio Vascular Concepts, 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 1, 1995. Regulation: 8.