Neurescue Device

Catheter, Intravascular Occluding, Temporary

Neurescue Aps

The following data is part of a premarket notification filed by Neurescue Aps with the FDA for Neurescue Device.

Pre-market Notification Details

Device IDK210358
510k NumberK210358
Device Name:Neurescue Device
ClassificationCatheter, Intravascular Occluding, Temporary
Applicant Neurescue Aps Kobmagergade 53, 2 Copenhagen,  DK 1150
ContactHabib Forest
CorrespondentSemih Oktay
CardioMed Device Consultants, LLC 1783 Forest Drive Suite 254 Annapolis,  MD  21401
Product CodeMJN  
Subsequent Product CodeDQO
Subsequent Product CodeDQY
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-05-21

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