510(k) K980493

I.V. CATHETER SYSTEM by Johnson & Johnson Medical, Inc. — Product Code FOZ

K980493 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "I.V. CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 1998. 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. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.