SAFEDWEL(R) CENTRAL VENOUS CATHETER

SAFEDWEL(R) CENTRAL VENOUS CATHETER is an FDA 510(k)-cleared medical device (K914528) manufactured by Becton Dickinson Vascular Access, 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 October 12, 1992. Regulation: 8.