K192083 is an FDA 510(k) clearance for the Okami Medical LOBO Vascular Occlusion System. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Okami Medical (Aliso Viejo, US). The FDA issued a Cleared decision on October 30, 2019, 89 days after receiving the submission on August 2, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K192083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2019 |
| Decision Date | October 30, 2019 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | KRD - Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |