Cleared Traditional

K182985 - Roadrunner PC Wire Guide, Olcott Torque Device

K182985 is an FDA 510(k) clearance for Roadrunner PC 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 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

FDA 510(k) Submission Details - K182985

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.

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 K182985.
Aristotle 24 Guidewire, 200cm, Soft Profile
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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