The following data is part of a premarket notification filed by Okami Medical with the FDA for Lobo Vascular Occlusion System (model Lobo-5).
| Device ID | K203025 |
| 510k Number | K203025 |
| Device Name: | LOBO Vascular Occlusion System (model LOBO-5) |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Okami Medical 8 Argonut Suite 100 Aliso Viejo, CA 92656 |
| Contact | Jill Delsman |
| Correspondent | Jill Delsman Okami Medical 8 Argonut Suite 100 Aliso Viejo, CA 92656 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-02 |
| Decision Date | 2020-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008222054 | K203025 | 000 |