Decision Date2016-10-20
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Fluent inflation device is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) 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. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K162272.
When did Fluent inflation device receive FDA 510(k) clearance?
Fluent inflation device received FDA 510(k) clearance on 2016-10-20, under 510(k) number K162272.
Who is the listed applicant for Fluent inflation device?
The FDA 510(k) record lists Vascular Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fluent inflation device?
The FDA product code for Fluent inflation device is MAV.
Other records listing Vascular Solutions, Inc. as applicant
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Related Devices (Code: MAV)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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 VascularK153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.