SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER

SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER is an FDA 510(k)-cleared medical device (K932777) 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 October 6, 1993. Regulation: 8.