THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602

THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 is an FDA 510(k)-cleared medical device (K960350) manufactured by Biocontrol Technology, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 1996. Regulation: 8.