510(k) K965023

CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE by Scimed Life Systems, Inc. — Product Code DQX

K965023 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on March 4, 1997. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Scimed Life Systems, Inc. has at least 10 other 510(k) clearances on record.