Cleared Special

ENCORE 26 ADVANTAGE KIT

K140745 · Boston Scientific Corp · Cardiovascular
Apr 2014
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K140745 is an FDA 510(k) clearance for the ENCORE 26 ADVANTAGE KIT, a Syringe, Balloon Inflation (Class II — Special Controls, product code MAV), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on April 17, 2014, 23 days after receiving the submission on March 25, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K140745 FDA.gov
FDA Decision Cleared SESK
Date Received March 25, 2014
Decision Date April 17, 2014
Days to Decision 23 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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