K240261 is an FDA 510(k) clearance for the Siege Vascular Plug (SVP2.5-0.021). This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 2, 2024, 92 days after receiving the submission on January 31, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K240261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2024 |
| Decision Date | May 02, 2024 |
| Days to Decision | 92 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 |