510(k) K103215

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT by Cianna Medical — Product Code JAQ

K103215 is an FDA 510(k) premarket notification submitted by Cianna Medical for the device "CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT". The FDA issued a decision of Substantially Equivalent on November 15, 2010. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Cianna Medical has at least 9 other 510(k) clearances on record.