510(k) K950752

ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS by Advanced Cardiovascular Systems, Inc. — Product Code DQX

K950752 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS". The FDA issued a decision of Substantially Equivalent on May 15, 1995. 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.