510(k) K090914

AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E by Xoft, Inc. — Product Code JAD

K090914 is an FDA 510(k) premarket notification submitted by Xoft, Inc. for the device "AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E". The FDA issued a decision of Substantially Equivalent - With Limitations on Jul 16, 2009. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Xoft, Inc. has 5 other 510(k) clearances on record.