510(k) K160860

MiniMed Quick-serter by Medtronic Minimed — Product Code KZH

K160860 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "MiniMed Quick-serter". The FDA issued a decision of Substantially Equivalent on September 22, 2016. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Medtronic Minimed has at least 10 other 510(k) clearances on record.