510(k) K082997

TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER by Terumo Medical Corp. — Product Code FOZ

K082997 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER". The FDA issued a decision of Substantially Equivalent on April 15, 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 Medical Corp. has at least 10 other 510(k) clearances on record.