Cleared Special

K130766 - ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

K130766 is an FDA 510(k) clearance for ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 119-day FDA review.

K130766 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
119d
Days
Class 2
Risk

K130766 is an FDA 510(k) clearance for the ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 17, 2013 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K130766

510(k) Number K130766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2013
Decision Date July 17, 2013
Days to Decision 119 days
Submission Type Special
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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

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 768
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K130766.
PRE-FORMED GUIDEWIRES
K130798 · Lake Region Medical, Inc. · Aug 2013
MERIT HYDROPHILIC GUIDE WIRE
K131710 · Merit Medical Systems, Inc. · Jul 2013
VDRIVE W/V-SONO
K122659 · Stereotaxis, Inc. · Jul 2013
VERRATA PRESSURE GUIDE WIRE
K131288 · Volcano Corporation · Jun 2013
GUIDEWIRE, PURSUER SERIES
K130104 · Oscor, Inc. · Jun 2013
MERIT HYDROPHILIC GUIDE WIRE
K130588 · Merit Medical Systems, Inc. · Apr 2013
K130766 · ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
Download PDF FDA Summary Cook, Inc.