510(k) K925161

NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO by North American Sterilization & Packaging Co. — Product Code KNY

K925161 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.