Cleared Traditional

Raider Guidewire

K173532 · Vascular Solutions, Inc. · Cardiovascular
Dec 2017
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K173532 is an FDA 510(k) clearance for the Raider 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 15, 2017, 30 days after receiving the submission on November 15, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K173532 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2017
Decision Date December 15, 2017
Days to Decision 30 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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