Cleared Special

Fluent inflation device

K162272 · Vascular Solutions, Inc. · Cardiovascular
Oct 2016
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K162272 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 October 20, 2016, 69 days after receiving the submission on August 12, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K162272 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2016
Decision Date October 20, 2016
Days to Decision 69 days
Submission Type Special
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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