510(k) K031678

HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING by Guidant Corp. — Product Code DQX

K031678 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING". The FDA issued a decision of Substantially Equivalent on August 26, 2003. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Guidant Corp. has at least 10 other 510(k) clearances on record.