510(k) K080563

RUNTHROUGH NS EXTENSION WIRE by Terumo Medical Corp. — Product Code DQX

K080563 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "RUNTHROUGH NS EXTENSION WIRE". The FDA issued a decision of Substantially Equivalent on March 20, 2008. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.