BD Saf-T-Intima™ Subcutaneous Catheter System

BD Saf-T-Intima™ Subcutaneous Catheter System is an FDA 510(k)-cleared medical device (K251422) manufactured by Becton Dickinson Infusion Therapy Systems, 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 7, 2025. Regulation: 8.