MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter is an FDA 510(k)-cleared medical device (K161779) manufactured by Medsource International, LLC. 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 November 2, 2016. Regulation: 8.