EMBOGUARD Balloon Guide Catheter

Catheter, Percutaneous, Neurovasculature

Neuravi Limited

The following data is part of a premarket notification filed by Neuravi Limited with the FDA for Emboguard Balloon Guide Catheter.

Pre-market Notification Details

Device IDK212340
510k NumberK212340
Device Name:EMBOGUARD Balloon Guide Catheter
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant Neuravi Limited Block 3, Ballybrit Business Park Galway,  IE H91 K5yd
ContactNiall Fox
CorrespondentNiall Fox
Neuravi Limited Block 3, Ballybrit Business Park Galway,  IE H91 K5yd
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-28
Decision Date2021-12-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704082743 K212340 000
10886704082736 K212340 000

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