510(k) K990236

MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT by Johnson & Johnson Medical, Div. of Ethicon, Inc. — Product Code FOZ

K990236 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Div. of Ethicon, Inc. for the device "MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT". The FDA issued a decision of Substantially Equivalent on August 20, 1999. 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, Div. of Ethicon, Inc. has at least 4 other 510(k) clearances on record.