RIST Radial Access Catheter

Catheter, Percutaneous

RIST Neurovascular, Inc.

The following data is part of a premarket notification filed by Rist Neurovascular, Inc. with the FDA for Rist Radial Access Catheter.

Pre-market Notification Details

Device IDK200417
510k NumberK200417
Device Name:RIST Radial Access Catheter
ClassificationCatheter, Percutaneous
Applicant RIST Neurovascular, Inc. 11611 Interchange Circle South Miramar,  FL  33025
ContactMarianne Grumwaldt
CorrespondentVyoma Upadhya Chikara
RIST Neurovascular, Inc. 11611 Interchange Circle South Miramar,  FL  33025
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-20
Decision Date2020-05-02

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