K220383 is an FDA 510(k) clearance for the LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9). 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 April 29, 2022, 78 days after receiving the submission on February 10, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K220383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2022 |
| Decision Date | April 29, 2022 |
| Days to Decision | 78 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 |