510(k) K812999

PET POLYETHYLENE TORQUE CATHETER by Universal Medical Instrument Corp. — Product Code DQO

K812999 is an FDA 510(k) premarket notification submitted by Universal Medical Instrument Corp. for the device "PET POLYETHYLENE TORQUE CATHETER". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Universal Medical Instrument Corp. has at least 10 other 510(k) clearances on record.