510(k) K070451

ABLE CENTRAL VENOUS CATHETER by Foshan Nanhai Bai HE Medical Technology Co., Ltd. — Product Code FOZ

K070451 is an FDA 510(k) premarket notification submitted by Foshan Nanhai Bai HE Medical Technology Co., Ltd. for the device "ABLE CENTRAL VENOUS CATHETER". The FDA issued a decision of Substantially Equivalent on July 31, 2007. 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. Foshan Nanhai Bai HE Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.