510(k) K043605

INSCOPE 3-STAGE BALLOON DILATOR by Cordis Europa, N.V. — Product Code KNQ

K043605 is an FDA 510(k) premarket notification submitted by Cordis Europa, N.V. for the device "INSCOPE 3-STAGE BALLOON DILATOR". The FDA issued a decision of Substantially Equivalent on February 4, 2005. 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.