Minjie Catheter System

Catheter, Percutaneous, Neurovasculature

Kai Medtech, LLC

The following data is part of a premarket notification filed by Kai Medtech, Llc with the FDA for Minjie Catheter System.

Pre-market Notification Details

Device IDK212288
510k NumberK212288
Device Name:Minjie Catheter System
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant Kai Medtech, LLC 22651 Lambert Street, Suite 107 Lake Forest,  CA  92630
ContactStephanie Rallis
CorrespondentRicardo Olivo
Kai Medtech, LLC 22651 Lambert Street, Suite 107 Lake Forest,  CA  92630
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-21
Decision Date2022-06-02

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