NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Nc Euphora Rapid Exchange Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK141090
510k NumberK141090
Device Name:NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant MEDTRONIC INC. PARKMORE BUSINESS PARK WEST Galway,  IE Ireland
ContactJohn Kilmartin
CorrespondentJohn Kilmartin
MEDTRONIC INC. PARKMORE BUSINESS PARK WEST Galway,  IE Ireland
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-28
Decision Date2014-08-15
Summary:summary

NIH GUDID Devices

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