LOBO Vascular Occlusion System (models LOBO-7 And LOBO-9)

Device, Vascular, For Promoting Embolization

Okami Medical

The following data is part of a premarket notification filed by Okami Medical with the FDA for Lobo Vascular Occlusion System (models Lobo-7 And Lobo-9).

Pre-market Notification Details

Device IDK220383
510k NumberK220383
Device Name:LOBO Vascular Occlusion System (models LOBO-7 And LOBO-9)
ClassificationDevice, Vascular, For Promoting Embolization
Applicant Okami Medical 8 Argonut Suite 100 Aliso Viejo,  CA  92656
ContactJill Delsman
CorrespondentJill Delsman
Okami Medical 8 Argonut Suite 100 Aliso Viejo,  CA  92656
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-10
Decision Date2022-04-29

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