Cleared Traditional

Endura guidewire

K161702 · Vascular Solutions, Inc. · Cardiovascular
Dec 2016
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K161702 is an FDA 510(k) clearance for the Endura guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on December 6, 2016, 169 days after receiving the submission on June 20, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K161702 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2016
Decision Date December 06, 2016
Days to Decision 169 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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