510(k) K911775

OMNICATH IMPLANTED CATHETER AND DEPOT by Omnitron Intl., Inc. — Product Code KXK

K911775 is an FDA 510(k) premarket notification submitted by Omnitron Intl., Inc. for the device "OMNICATH IMPLANTED CATHETER AND DEPOT". The FDA issued a decision of Substantially Equivalent on May 8, 1991. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Omnitron Intl., Inc. has at least 6 other 510(k) clearances on record.