Cleared Special

basixTOUCH40 Inflation Syringe

K153672 · Merit Medical Systems, Inc. · Cardiovascular
Jan 2016
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K153672 is an FDA 510(k) clearance for the basixTOUCH40 Inflation Syringe, a Syringe, Balloon Inflation (Class II — Special Controls, product code MAV), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 20, 2016, 30 days after receiving the submission on December 21, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K153672 FDA.gov
FDA Decision Cleared SESK
Date Received December 21, 2015
Decision Date January 20, 2016
Days to Decision 30 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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