Cleared Traditional

K181353 - Lunderquist® Fixed Core Wire Guide

K181353 is an FDA 510(k) clearance for Lunderquist Fixed Core Wire Guide, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K181353 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
269d
Days
Class 2
Risk

K181353 is an FDA 510(k) clearance for the Lunderquist® Fixed Core Wire Guide. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 15, 2019 after a review of 269 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 Cook Incorporated devices

FDA 510(k) Submission Details - K181353

510(k) Number K181353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2018
Decision Date February 15, 2019
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K181353.
ASAHI Silverway
K183062 · Asahi Intecc Co., Ltd. · Jul 2019
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
K182457 · Brivant Limited (Lake Region Medical) · Apr 2019
Inno-Pathwire
K182553 · Suzhou Innomed Medical Device Co., Ltd. · Mar 2019
Roadrunner Extra Support Wire Guide
K183467 · Cook Incorporated · Jan 2019
Reuter Tip Deflecting Wire Guide
K180830 · Cook Incorporated · Dec 2018
Magic Torque DLVR Guidewire
K182315 · Boston Scientific Corporation · Sep 2018