Concerto Versa Detachable Coil
FDA 510(k) K253511 · Medtronic, Inc.
510(k) numberK253511
Submission
- Device name
- Concerto Versa Detachable Coil
- Applicant
- Medtronic, Inc.
Plymouth, MN, US - Received
- November 5, 2025
- Decision date
- January 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
| K251383 | Prestige Coil System (Prestige Packing Line Extension)KRD · Special | Balt USA, LLC | 05/30/2025SE |
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| K261335 | VitalFlow Set with Balance BiosurfaceQJZ · Traditional | 07/31/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | 06/24/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | 05/28/2026SE |
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| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | 02/19/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | 01/20/2026SE |
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Questions and answers
When was Concerto Versa Detachable Coil cleared by the FDA?
Concerto Versa Detachable Coil (K253511) received a 510(k) decision of Substantially Equivalent on January 14, 2026, 70 days after the submission was received.
What is the product code of K253511?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.