Roadrunner Wire Guide, Modification
FDA 510(k)Class II (US FDA 510(k))
by Cook, Inc.
Identifiers
- 510(k) Number
- K920891 FDA 510(k)
- FDA Product Code
- DQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Roadrunner Wire Guide, Modification is a wire guide designed for vascular access procedures. It features a nitinol core, a hydrophilic coating, and a flexible platinum tip, enabling enhanced trackability and reduced friction within blood vessels. This modification maintains compatibility with existing procedural workflows while improving navigation through complex anatomical pathways.
This device is supplied as a single-use, non-sterile item and requires sterilization prior to use. It is classified under product code DQX and holds FDA 510(k) clearance (K920891) with a Traditional review pathway. The device is intended for use in interventional cardiology settings and must be handled according to standard aseptic techniques. No additional regulatory markings or MRI safety classifications are specified.
Frequently asked questions
What is the Roadrunner Wire Guide, Modification specifically designed to improve during vascular access procedures?
The Roadrunner Wire Guide, Modification is designed to improve navigation through complex blood vessels by incorporating a nitinol core for enhanced flexibility and durability, a hydrophilic coating to reduce friction, and a flexible platinum tip. These features collectively enhance trackability, making it easier to maneuver through challenging anatomical pathways during interventional cardiology procedures.
Is the Roadrunner Wire Guide, Modification intended for reuse, or is it meant to be used only once?
The Roadrunner Wire Guide, Modification is explicitly supplied as a single-use device and is non-sterile at the time of shipment. It must be sterilized prior to use, following standard aseptic techniques, to ensure safety and efficacy in vascular access procedures.
How should I store the Roadrunner Wire Guide, Modification before sterilization?
While the provided data does not specify exact storage conditions, as a single-use, non-sterile device requiring sterilization, it should be stored in a clean, dry environment protected from contamination. Follow manufacturer guidelines for sterilization (e.g., ethylene oxide, autoclave, or other validated methods) to ensure it remains safe for use in interventional cardiology procedures.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?
The Roadrunner Wire Guide, Modification received FDA clearance through the Traditional 510(k) review pathway, with a Substantially Equivalent (SESE) determination. The review was conducted under the Cardiovascular (CV) advisory committee, reflecting its intended use in interventional cardiology settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Roadrunner® PC Hydrophilic Wire Guide - Cook Medical, ROADRUNNER (TM) WIRE GUIDE, MODIFICATION (K920891) — FDA 510 (k ..., Wire Guides | Cook Medical, Roadrunner(tm) Wire Guide, Modification 510(k) K920891 - fda.report, www.accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920891 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA 510(k) K920891 24 fields · synced Sep 19, 2026