MIVI Q Distal Access Catheter

Catheter, Percutaneous, Neurovasculature

MIVI Neuroscience, Inc.

The following data is part of a premarket notification filed by Mivi Neuroscience, Inc. with the FDA for Mivi Q Distal Access Catheter.

Pre-market Notification Details

Device IDK212402
510k NumberK212402
Device Name:MIVI Q Distal Access Catheter
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant MIVI Neuroscience, Inc. 6545 City West Parkway Eden Prairie,  MN  55443
ContactJanel Hurtado
CorrespondentJanel Hurtado
MIVI Neuroscience, Inc. 6545 City West Parkway Eden Prairie,  MN  55443
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2021-12-16

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