Cleared Traditional

MASTRO PLUS BALLOON IN-DEFLATION DEVICE

K140943 · Beijing Demax Medical Technology Co.,Ltd · Cardiovascular
Mar 2015
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K140943 is an FDA 510(k) clearance for the MASTRO PLUS BALLOON IN-DEFLATION DEVICE, a Syringe, Balloon Inflation (Class II — Special Controls, product code MAV), submitted by Beijing Demax Medical Technology Co.,Ltd (Guangzhou, CN). The FDA issued a Cleared decision on March 5, 2015, 325 days after receiving the submission on April 14, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K140943 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2014
Decision Date March 05, 2015
Days to Decision 325 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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