K253511 is an FDA 510(k) clearance for the Concerto Versa™ Detachable Coil. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Medtronic, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 14, 2026, 70 days after receiving the submission on November 5, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K253511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2025 |
| Decision Date | January 14, 2026 |
| Days to Decision | 70 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 |