Concerto Versa™ Detachable Coil
FDA 510(k) clearance K253511 · decided 2026-01-14
Clearance details
- K-number
- K253511
- Device name
- Concerto Versa™ Detachable Coil
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-05
- Decision date
- 2026-01-14
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KRD
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
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| Tembo Embolic System (K253677) | Instylla, Inc. | 2025-12-15 |
| OBSIDIO™ Conformable Embolic (M0013972101010) (K253376) | Boston Scientific Corporation | 2025-10-30 |
| Polyvinyl Alcohol Embolic Microspheres (K250209) | Canyon Medical, Inc. | 2025-09-23 |
| HARBOR Occlusion Device (K250133) | Nuvascular, Inc. | 2025-07-09 |
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| Embosphere Microspheres (K250971) | Biosphere Medical, S.A. | 2025-05-16 |
| Nitinol Enhanced Device (NED) (K250276) | Embolization, Inc. | 2025-05-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527) | Medtronic, Inc. | 2025-12-22 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574) | Medtronic, Inc. | 2025-12-19 |
| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 2025-12-17 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |