Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter

Catheter, Percutaneous

MIVI Neurovascular

The following data is part of a premarket notification filed by Mivi Neurovascular with the FDA for Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6distal Access Catheter.

Pre-market Notification Details

Device IDK192558
510k NumberK192558
Device Name:Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
ClassificationCatheter, Percutaneous
Applicant MIVI Neurovascular 6545 City West Parkway Eden Prairie,  MN  55344
ContactJanel Hurtado
CorrespondentJanel Hurtado
MIVI Neurovascular 6545 City West Parkway Eden Prairie,  MN  55344
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-17
Decision Date2020-04-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.