510(k) K961015

SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE by Scimed Life Systems, Inc. — Product Code DQX

K961015 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on May 15, 1996. 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.