EMBOTRAP III Revascularization Device

Catheter, Thrombus Retriever

Neuravi, Ltd.

The following data is part of a premarket notification filed by Neuravi, Ltd. with the FDA for Embotrap Iii Revascularization Device.

Pre-market Notification Details

Device IDK193063
510k NumberK193063
Device Name:EMBOTRAP III Revascularization Device
ClassificationCatheter, Thrombus Retriever
Applicant Neuravi, Ltd. Block 3, Ballybrit Business Park, Galway,  IE H91 K5yd
ContactNiall Fox
CorrespondentNiall Fox
Neuravi, Ltd. Block 3, Ballybrit Business Park, Galway,  IE H91 K5yd
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-04
Decision Date2020-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000
10886704084570 K193063 000
10886704082866 K193063 000

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