510(k) K140803

LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM by Nucletron B.V. — Product Code JAQ

K140803 is an FDA 510(k) premarket notification submitted by Nucletron B.V. for the device "LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM". The FDA issued a decision of Substantially Equivalent on June 26, 2014. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron B.V. has at least 10 other 510(k) clearances on record.