SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION

SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION is an FDA 510(k)-cleared medical device (K940804) 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 June 9, 1994. Regulation: 8.