Cleared Traditional

ENROUTE 0.014 Guidewire

K160643 · Lake Region Medical · Cardiovascular
Oct 2016
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K160643 is an FDA 510(k) clearance for the ENROUTE 0.014 Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Lake Region Medical (Galway, IE). The FDA issued a Cleared decision on October 18, 2016, 225 days after receiving the submission on March 7, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K160643 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2016
Decision Date October 18, 2016
Days to Decision 225 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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