Medtronic Confida Brecker Guidewire

Wire, Guide, Catheter

Medtronic CoreValve, LLC.

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

Pre-market Notification Details

Device IDK150465
510k NumberK150465
Device Name:Medtronic Confida Brecker Guidewire
ClassificationWire, Guide, Catheter
Applicant Medtronic CoreValve, LLC. 3576 Unocal Place Santa Rosa,  CA  95403
ContactGenevieve Balutowski Dunbar
CorrespondentMatthew Lobeck
Medtronic CoreValve, LLC. 3576 Unocal Place Santa Rosa,  CA  95403
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-23
Decision Date2015-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169583737 K150465 000

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