510(k) K914986

GUIDE WIRES, MODIFICATION by E-Z-Em, Inc. — Product Code DQX

K914986 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "GUIDE WIRES, MODIFICATION". The FDA issued a decision of Substantially Equivalent on May 20, 1992. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.