The following data is part of a premarket notification filed by Okami Medical with the FDA for Okami Medical Lobo Vascular Occlusion System.
| Device ID | K192083 |
| 510k Number | K192083 |
| Device Name: | Okami Medical LOBO Vascular Occlusion System |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Okami Medical 8 Argonaut, Suite 100 Aliso Viejo, CA 92656 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine Okami Medical 8 Argonaut, Suite 100 Aliso Viejo, CA 92656 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-02 |
| Decision Date | 2019-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008222016 | K192083 | 000 |
| 00850008222009 | K192083 | 000 |