Intri24 Sheath

Introducer, Catheter

Inari Medical, Inc.

The following data is part of a premarket notification filed by Inari Medical, Inc. with the FDA for Intri24 Sheath.

Pre-market Notification Details

Device IDK212392
510k NumberK212392
Device Name:Intri24 Sheath
ClassificationIntroducer, Catheter
Applicant Inari Medical, Inc. 9 Parker, Suite 100 Irvine,  CA  92618
ContactKit Cariquitan
CorrespondentKit Cariquitan
Inari Medical, Inc. 9 Parker, Suite 100 Irvine,  CA  92618
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2022-04-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850291007260 K212392 000

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