RIST Cath Radial Access Long Sheath

Catheter, Percutaneous

RIST Neurovascular, Inc.

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

Pre-market Notification Details

Device IDK191551
510k NumberK191551
Device Name:RIST Cath Radial Access Long Sheath
ClassificationCatheter, Percutaneous
Applicant RIST Neurovascular, Inc. 11611 Interchange Circle S Miramar,  FL  33025
ContactMarianne Grumwaldt
CorrespondentElena Jugo
Caraballo Consulting 11037 Bitternut Hickory Lane Boynton Beach,  FL  33437
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-12
Decision Date2019-12-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000413781 K191551 000
00763000413774 K191551 000
00763000413767 K191551 000

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