Cleared Traditional

K181353 - Lunderquist Fixed Core Wire Guide

K181353 is the FDA 510(k) clearance for Lunderquist Fixed Core Wire Guide by Cook Incorporated. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 498
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