510(k) K061453

HI-TORQUE WHISPER VIEW GUIDE WIRE by Guidant Corp. — Product Code DQX

K061453 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "HI-TORQUE WHISPER VIEW GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on June 22, 2006. 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.