Cleared Special

Pre-Formed Guidewire

K151244 · Lake Region Medical · Cardiovascular
Jun 2015
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K151244 is an FDA 510(k) clearance for the Pre-Formed Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Lake Region Medical (Chaska, US). The FDA issued a Cleared decision on June 11, 2015, 31 days after receiving the submission on May 11, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K151244 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2015
Decision Date June 11, 2015
Days to Decision 31 days
Submission Type Special
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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