510(k) K923480

SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA by Scimed Life Systems, Inc. — Product Code DQO

K923480 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA". The FDA issued a decision of Substantially Equivalent on Oct 6, 1992. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.