K242507 is an FDA 510(k) clearance for the OBSIDIO™ Conformable Embolic. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on October 3, 2024, 42 days after receiving the submission on August 22, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K242507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2024 |
| Decision Date | October 03, 2024 |
| Days to Decision | 42 days |
| Submission Type | Special |
| 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 |