510(k) K863178

UMI STEERABLE TORQUE GUIDE WIRE by Universal Medical Instrument Corp. — Product Code DQX

K863178 is an FDA 510(k) premarket notification submitted by Universal Medical Instrument Corp. for the device "UMI STEERABLE TORQUE GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on September 19, 1986. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Universal Medical Instrument Corp. has at least 10 other 510(k) clearances on record.