510(k) K082836

ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES by Icu Medical, Inc. — Product Code FMG

K082836 is an FDA 510(k) premarket notification submitted by Icu Medical, Inc. for the device "ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES". The FDA issued a decision of Substantially Equivalent on February 25, 2009. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Icu Medical, Inc. has at least 10 other 510(k) clearances on record.