510(k) K791918

JELCO WINGED INTRAVASCULAR CATHETER by Jelco Laboratories — Product Code FOZ

K791918 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "JELCO WINGED INTRAVASCULAR CATHETER". The FDA issued a decision of Substantially Equivalent on October 2, 1979. 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. Jelco Laboratories has at least 10 other 510(k) clearances on record.