Cleared Traditional

K172090 - GuideLiner V3 Catheter

K172090 is an FDA 510(k) clearance for GuideLiner V3 Catheter, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

K172090 is an FDA 510(k) clearance for the GuideLiner V3 Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 20, 2017 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K172090

510(k) Number K172090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 646
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K172090.
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
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Microcatheter
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Attain Assist CS Access Catheter
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MAMBA and MAMBA FLEX Microcatheters
K171452 · Boston Scientific Corporation · Aug 2017
AXS Offset Delivery Assist Catheter
K163259 · Stryker Neurovascular · Jul 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · Boston Scientific Corporation · Jul 2017