510(k) K100282

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER by Terumo Corp. — Product Code FOZ

K100282 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER". The FDA issued a decision of Substantially Equivalent on February 26, 2010. 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.