510(k) K091598

LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS by Nucletron Corp. — Product Code JAQ

K091598 is an FDA 510(k) premarket notification submitted by Nucletron Corp. for the device "LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS". The FDA issued a decision of Substantially Equivalent on June 29, 2009. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron Corp. has at least 10 other 510(k) clearances on record.