Cleared Special

Spectre guidewire

K163444 · Vascular Solutions, Inc. · Cardiovascular
Jan 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K163444 is an FDA 510(k) clearance for the Spectre 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 January 6, 2017, 29 days after receiving the submission on December 8, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K163444 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2016
Decision Date January 06, 2017
Days to Decision 29 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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