WHOLEY GUIDE WIRE SYSTEM

Wire, Guide, Catheter

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Wholey Guide Wire System.

Pre-market Notification Details

Device IDK120863
510k NumberK120863
Device Name:WHOLEY GUIDE WIRE SYSTEM
ClassificationWire, Guide, Catheter
Applicant Covidien LLC 3033 Campus Drive Plymouth,  MN  55441
ContactDavid Rbertson
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-03-22
Decision Date2012-04-19
Summary:summary

NIH GUDID Devices

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