510(k) K060302

INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED by Cordis Europa, N.V. — Product Code KNQ

K060302 is an FDA 510(k) premarket notification submitted by Cordis Europa, N.V. for the device "INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED". The FDA issued a decision of Substantially Equivalent on April 11, 2006. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Cordis Europa, N.V. has at least 6 other 510(k) clearances on record.