510(k) K071382

SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, by Shinchang Medical Co., Ltd. — Product Code FOZ

K071382 is an FDA 510(k) premarket notification submitted by Shinchang Medical Co., Ltd. for the device "SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,". The FDA issued a decision of Substantially Equivalent on October 16, 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. Shinchang Medical Co., Ltd. has at least 2 other 510(k) clearances on record.