510(k) K142797

I.V. Catheter by Jiangxi Sanxin Medtec Co., Ltd. — Product Code FOZ

K142797 is an FDA 510(k) premarket notification submitted by Jiangxi Sanxin Medtec Co., Ltd. for the device "I.V. Catheter". The FDA issued a decision of Substantially Equivalent on June 18, 2015. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Jiangxi Sanxin Medtec Co., Ltd. has at least 2 other 510(k) clearances on record.