510(k) K122544

TERUMO SURFLASH SAFETY I.V. CATHETER by Terumo Corporation — Product Code FOZ

K122544 is an FDA 510(k) premarket notification submitted by Terumo Corporation for the device "TERUMO SURFLASH SAFETY I.V. CATHETER". The FDA issued a decision of Substantially Equivalent on Sep 5, 2012. 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. Terumo Corporation has at least 10 other 510(k) clearances on record.