Cleared Traditional

GuideLiner V3 Catheter

K172090 · Vascular Solutions, Inc. · Cardiovascular
Oct 2017
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K172090 is an FDA 510(k) clearance for the GuideLiner V3 Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on October 20, 2017, 101 days after receiving the submission on July 11, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K172090 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2017
Decision Date October 20, 2017
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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