Cleared Traditional

Fluent Inflation Device

K152387 · Vascular Solutions, Inc. · Cardiovascular
Dec 2015
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K152387 is an FDA 510(k) clearance for the Fluent Inflation Device, a Syringe, Balloon Inflation (Class II — Special Controls, product code MAV), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on December 18, 2015, 116 days after receiving the submission on August 24, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K152387 FDA.gov
FDA Decision Cleared SESK
Date Received August 24, 2015
Decision Date December 18, 2015
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MAV — Syringe, Balloon Inflation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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