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 Euphora Rapid Exchange Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK143480
510k NumberK143480
Device Name:Euphora Rapid Exchange Balloon Dilatation Catheter
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant MEDTRONIC INC. PARKMORE BUSINESS PARK WEST Galway,  IE
ContactJohn Kilmartin
CorrespondentElaine Gullane
MEDTRONIC INC. PARKMORE BUSINESS PARK WEST Galway,  IE
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-08
Decision Date2015-04-02
Summary:summary

NIH GUDID Devices

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