510(k) K012534

HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING by Advanced Cardiovascular Systems, Inc. — Product Code DQX

K012534 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING". The FDA issued a decision of Substantially Equivalent on January 24, 2002. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Advanced Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.