510(k) K163358

Introcan Safety 3 Closed IV Catheter by B.Braun Melsungen AG — Product Code FOZ

K163358 is an FDA 510(k) premarket notification submitted by B.Braun Melsungen AG for the device "Introcan Safety 3 Closed IV Catheter". The FDA issued a decision of Substantially Equivalent on April 28, 2017. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. B.Braun Melsungen AG has at least 4 other 510(k) clearances on record.