510(k) K853182

DIAGNOSTIC INTRAVASCULAR CATHETERS by Mallinckrodt Critical Care — Product Code DQO

K853182 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "DIAGNOSTIC INTRAVASCULAR CATHETERS". The FDA issued a decision of Substantially Equivalent on January 15, 1986. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.