Cleared Traditional

VENTED MILLEX -GV, CATHIVEX -GV

K133004 · Merck Millipore , Ltd. · Anesthesiology
Mar 2014
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K133004 is an FDA 510(k) clearance for the VENTED MILLEX -GV, CATHIVEX -GV, a Filter, Conduction, Anesthetic (Class II — Special Controls, product code BSN), submitted by Merck Millipore , Ltd. (Temecula, US). The FDA issued a Cleared decision on March 27, 2014, 183 days after receiving the submission on September 25, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5130.

Submission Details

510(k) Number K133004 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2013
Decision Date March 27, 2014
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSN — Filter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5130

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