Decision Date2016-10-20
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Fluent inflation device is a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2016-10-20 under approval number K162272. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fluent inflation device?
Fluent inflation device is a medical device that received FDA 510(k) clearance on 2016-10-20. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K162272.
When was Fluent inflation device approved by the FDA?
Fluent inflation device received FDA 510(k) clearance on 2016-10-20, under approval number K162272.
What company makes Fluent inflation device?
Fluent inflation device is manufactured by Vascular Solutions, Inc..
What is the FDA product code for Fluent inflation device?
The FDA product code for Fluent inflation device is MAV.
Related Devices (Code: MAV)
K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.
K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.
K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)Medtronic Vascular
Official Source
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