Cleared Traditional

K182985 - Roadrunner PC Wire Guide

K182985 is the FDA 510(k) clearance for Roadrunner PC Wire Guide by Cook Incorporated. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K182985 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
266d
Days
Class 2
Risk

K182985 is an FDA 510(k) clearance for the Roadrunner PC Wire Guide, Olcott Torque Device. 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 July 22, 2019 after a review of 266 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 K182985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2018
Decision Date July 22, 2019
Days to Decision 266 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
141d slower than avg
Panel avg: 125d · This submission: 266d
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 K182985.
Aristotle 24 Guidewire, 200cm, Soft Profile
K192783 · Scientia Vascular, LLC · Oct 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
K191687 · Phenox Limited · Oct 2019
MINAMO
K190176 · Asahi Intecc Co., Ltd. · Aug 2019
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