Cleared Traditional

BASIXCONPAK ANALOG INFLATION SYRINGE

K122321 · Merit Medical Ireland, Ltd. · Cardiovascular
Dec 2012
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K122321 is an FDA 510(k) clearance for the BASIXCONPAK ANALOG INFLATION SYRINGE, a Syringe, Balloon Inflation (Class II — Special Controls, product code MAV), submitted by Merit Medical Ireland, Ltd. (South Jordan, US). The FDA issued a Cleared decision on December 19, 2012, 140 days after receiving the submission on August 1, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K122321 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2012
Decision Date December 19, 2012
Days to Decision 140 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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