Cleared Traditional

OptoWire III

K191907 · Opsens, Inc. · Cardiovascular
Jan 2020
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K191907 is an FDA 510(k) clearance for the OptoWire III, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on January 2, 2020, 170 days after receiving the submission on July 16, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K191907 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2019
Decision Date January 02, 2020
Days to Decision 170 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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