510(k) K090973

TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) by Terumo Corp. — Product Code FOZ

K090973 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)". The FDA issued a decision of Substantially Equivalent on May 1, 2009. 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 Corp. has at least 10 other 510(k) clearances on record.