Okami Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260508LOBO Vascular Occlusion SystemApril 10, 2026
K242644SENDERO MAX Delivery CatheterDecember 20, 2024
K240384SENDERO MicrocatheterMarch 8, 2024
K231600SENDERO MicrocatheterNovember 17, 2023
K220383LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)April 29, 2022
K203025LOBO Vascular Occlusion System (model LOBO-5)November 5, 2020
K192083Okami Medical LOBO Vascular Occlusion SystemOctober 30, 2019