510(k) K021228

HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE by Guidant Corp. — Product Code DQX

K021228 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE". The FDA issued a decision of Substantially Equivalent on May 15, 2002. 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.