510(k) K992169

ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE by Advanced Cardiovascular Systems, Inc. — Product Code DQX

K992169 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on October 28, 1999. 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.