Okami Medical Inc.
Aliso Viejo, CA, US
Okami Medical Inc. appears in FDA device records in Aliso Viejo, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Okami Medical Inc. between 2019 and 2026. The busiest year on record is 2024, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260508 | LOBO Vascular Occlusion System | KRD | Substantially Equivalent | |
| K242644 | SENDERO MAX Delivery Catheter | DQY | Substantially Equivalent | |
| K240384 | SENDERO Microcatheter | DQY | Substantially Equivalent | |
| K231600 | SENDERO Microcatheter | DQY | Substantially Equivalent | |
| K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | KRD | Substantially Equivalent | |
| K203025 | LOBO Vascular Occlusion System (model LOBO-5) | KRD | Substantially Equivalent | |
| K192083 | Okami Medical LOBO Vascular Occlusion System | KRD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016444913 | 3016444913 | Okami Medical Inc. | 8 Argonaut, Aliso Viejo, CA 92656 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain