K213398 is an FDA 510(k) clearance for the EMBOLD Fibered Detachable Coil System. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on April 12, 2022, 176 days after receiving the submission on October 18, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K213398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2021 |
| Decision Date | April 12, 2022 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRD — Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |