Roadrunner Extra Support Wire Guide

Wire, Guide, Catheter

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Roadrunner Extra Support Wire Guide.

Pre-market Notification Details

Device IDK183467
510k NumberK183467
Device Name:Roadrunner Extra Support Wire Guide
ClassificationWire, Guide, Catheter
Applicant Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
ContactDaniel J. Corbin
CorrespondentDaniel J. Corbin
Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-14
Decision Date2019-01-11

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