SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM

SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM is an FDA 510(k)-cleared medical device (K913746) manufactured by Peripheral Systems Group. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 1991. Regulation: 8.