510(k) K153038

Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit by Medtronic, Inc. — Product Code MAV

K153038 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit". The FDA issued a decision of Substantially Equivalent (kit) on April 13, 2016. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Medtronic, Inc. has at least 10 other 510(k) clearances on record.