510(k) K111236

INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 by B.Braun Melsungen AG — Product Code FOZ

K111236 is an FDA 510(k) premarket notification submitted by B.Braun Melsungen AG for the device "INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1". The FDA issued a decision of Substantially Equivalent on August 30, 2011. 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.