510(k) K030617

PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE by Boston Scientific Scimed, Inc. — Product Code DQX

K030617 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE". The FDA issued a decision of Substantially Equivalent on May 21, 2003. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.