Cleared Traditional

K171513 - Lunderquist Extra Stiff Wire Guide

K171513 is an FDA 510(k) clearance for Lunderquist Extra Stiff Wire Guide, manufactured by William Cook Europe Aps. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K171513 · William Cook Europe Aps · Cardiovascular device
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Dec 2017
Decision
197d
Days
Class 2
Risk

K171513 is an FDA 510(k) clearance for the Lunderquist Extra Stiff Wire Guide. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on December 7, 2017 after a review of 197 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 William Cook Europe Aps devices

FDA 510(k) Submission Details - K171513

510(k) Number K171513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2017
Decision Date December 07, 2017
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 542
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K171513.
Amplatz Support Wire Guide with Apex Curve
K171445 · Cook Incorporated · Jan 2018
Roadrunner Extra Support Wire Guide
K171948 · Cook Incorporated · Jan 2018
Raider Guidewire
K173532 · Vascular Solutions, Inc. · Dec 2017
WATCHDOG Hemostasis Valve Kit
K172453 · Boston Scientific Corporation · Nov 2017
Hi-Torque Command 18 Guide Wire
K172073 · Abbott Vascular · Aug 2017
Approach CTO Microwire Guide
K171897 · Cook Incorporated · Aug 2017