MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE

Wire, Guide, Catheter

Medtronic

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

Pre-market Notification Details

Device IDK132623
510k NumberK132623
Device Name:MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
ClassificationWire, Guide, Catheter
Applicant Medtronic 3576 UNOCAL PL Santa Rosa,  CA  95403
ContactMonica Hernandez-soto
CorrespondentMonica Hernandez-soto
Medtronic 3576 UNOCAL PL Santa Rosa,  CA  95403
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-22
Decision Date2013-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169357055 K132623 000

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