510(k) K910969

TORQUE DEVICE FOR A GUIDE WIRE by Terumo Corp. — Product Code DQX

K910969 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "TORQUE DEVICE FOR A GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on May 16, 1991. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Terumo Corp. has at least 10 other 510(k) clearances on record.