Cleared Traditional

Opto Wire and OptoMonitor System

K142598 · Opsens, Inc. · Cardiovascular
Jun 2015
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K142598 is an FDA 510(k) clearance for the Opto Wire and OptoMonitor System, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on June 12, 2015, 270 days after receiving the submission on September 15, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K142598 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2014
Decision Date June 12, 2015
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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