510(k) K171346

Sapphire Sets by Icu Medical — Product Code MRZ

K171346 is an FDA 510(k) premarket notification submitted by Icu Medical for the device "Sapphire Sets". The FDA issued a decision of Substantially Equivalent on August 25, 2017. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Icu Medical has at least 10 other 510(k) clearances on record.