510(k) K140129

PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER by Icu Medical, Inc. — Product Code DQE

K140129 is an FDA 510(k) premarket notification submitted by Icu Medical, Inc. for the device "PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER". The FDA issued a decision of Substantially Equivalent on July 2, 2014. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Icu Medical, Inc. has at least 10 other 510(k) clearances on record.