EmboTrap Ll 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 Ll Revascularization Device.

Pre-market Notification Details

Device IDK173452
510k NumberK173452
Device Name:EmboTrap Ll Revascularization Device
ClassificationCatheter, Thrombus Retriever
Applicant Neuravi Ltd. Block 3, Ballybrit Business Park Galway,  IE
ContactMairsil Claffey
CorrespondentMairsil Claffey
Neuravi Ltd. Block 3, Ballybrit Business Park Galway,  IE
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-06
Decision Date2018-05-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704081326 K173452 000
10886704081319 K173452 000

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