
Xoft, Inc.
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AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E is an FDA 510(k)-cleared medical device (K090914) manufactured by Xoft, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2009. Regulation: 8.