510(k) K063238

ULTRACLIP II WING AND ULTRACLIP II COIL by Inrad — Product Code NEU

K063238 is an FDA 510(k) premarket notification submitted by Inrad for the device "ULTRACLIP II WING AND ULTRACLIP II COIL". The FDA issued a decision of Substantially Equivalent on Jan 30, 2007. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Inrad has at least 10 other 510(k) clearances on record.