Medtronic Confida Brecker Guidewire

Wire, Guide, Catheter

Medtronic Core Valve, LLC.

The following data is part of a premarket notification filed by Medtronic Core Valve, Llc. with the FDA for Medtronic Confida Brecker Guidewire.

Pre-market Notification Details

Device IDK181001
510k NumberK181001
Device Name:Medtronic Confida Brecker Guidewire
ClassificationWire, Guide, Catheter
Applicant Medtronic Core Valve, LLC. Parkmore West Galway,  IE
ContactGerardine Drummond
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 Received2018-04-16
Decision Date2018-05-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20763000060880 K181001 000
20763000758640 K181001 000

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