Okami Medical LOBO Vascular Occlusion System

Device, Vascular, For Promoting Embolization

Okami Medical

The following data is part of a premarket notification filed by Okami Medical with the FDA for Okami Medical Lobo Vascular Occlusion System.

Pre-market Notification Details

Device IDK192083
510k NumberK192083
Device Name:Okami Medical LOBO Vascular Occlusion System
ClassificationDevice, Vascular, For Promoting Embolization
Applicant Okami Medical 8 Argonaut, Suite 100 Aliso Viejo,  CA  92656
ContactRebecca K Pine
CorrespondentRebecca K Pine
Okami Medical 8 Argonaut, Suite 100 Aliso Viejo,  CA  92656
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-02
Decision Date2019-10-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850008222016 K192083 000
00850008222009 K192083 000

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