510(k) K934602

ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE by Advanced Cardiovascular Systems, Inc. — Product Code DQX

K934602 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on December 16, 1993. 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.