FDA.reportPublic FDA data

Okami Medical Inc.

Matched from indexed company URL: Okami Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30164449133016444913Okami Medical Inc.1N2026-01-018 Argonaut Suite 100 Aliso Viejo CA US 92656

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850008222009LOBO - LOBO Handpiece9494469710info@okamimedical.com
00850008222016LOBO - Peripheral Vascular Occluder9494469710info@okamimedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2358101994222698K260508LOBO Vascular Occlusion SystemKRD2026-04-10
2358102000232636K242644SENDERO MAX Delivery CatheterDQY2024-12-20
2358101026797549K240384SENDERO MicrocatheterDQY2024-03-08
2358101380912184K220383LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)KRD2022-04-29
2358101643541176K203025LOBO Vascular Occlusion System (model LOBO-5)KRD2020-11-05
2358101337987197K192083Okami Medical LOBO Vascular Occlusion SystemKRD2019-10-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRD42026-04-10
DQY22024-12-20

PMN#

GUDID#