Concerto Versa™
Concerto Versa is a detachable embolization coil for arteries and veins in the peripheral vasculature. A platinum-tungsten implant coil is attached to a composite delivery pusher for…
Concerto Versa is a detachable embolization coil for arteries and veins in the peripheral vasculature. A platinum-tungsten implant coil is attached to a composite delivery pusher for placement at the selected site.
A separate handheld Instant Detacher releases the coil from the tip of the pusher when activated. The detacher is an accessory sold separately from the sterile, single-use coil.
Listed Item
Coil Concerto Versa CV-4-5 US
Coil Configurations
The range includes spherical and multispherical coil shapes, with loop outside diameters from 3 to 32 mm and coil lengths from 5 to 65 cm. The coil remains as the embolization implant after detachment, while the delivery pusher is withdrawn.
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Suzhou Haowei Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K253511 |
| Record published | 2026-02-27 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CV-24-65 | Coil Outer Diameter: 20.1 mm | In distribution |
| CV-9-20 | Implant Outer Diameter: 0.57 mm | In distribution |
| CV-32-40 | Coil Outer Diameter: 26.7 mm | In distribution |
| CV-28-65 | Implant Outer Diameter: 0.57 mm | In distribution |
| CV-12-50 | Coil Outer Diameter: 14.4 mm | In distribution |
| CV-10-40 | Coil Outer Diameter LARGE: 10 mm | In distribution |
| CV-7-40 | Coil Outer Diameter LARGE: 7 mm | In distribution |
| CV-10-20 | Coil Length: 20 cm | In distribution |
| CV-16-40 | Coil Outer Diameter: 13.5 mm | In distribution |
| CV-5-20 | Coil Length: 20 cm | In distribution |
| CV-32-65 | Compatible Catheter Inner Diameter: 0.69-1.07 mm | In distribution |
| CV-14-65 | Coil Outer Diameter: 16.8 mm | In distribution |
| CV-3-15 | Coil Outer Diameter: 3.6 mm | In distribution |
| CV-20-65 | Implant Outer Diameter: 0.57 mm | In distribution |
| CV-18-40 | Compatible Catheter Inner Diameter: 0.69-1.07 mm | In distribution |
| CV-14-40 | Compatible Catheter Inner Diameter: 0.69-1.07 mm | In distribution |
| CV-20-40 | Implant Outer Diameter: 0.57 mm | In distribution |
| CV-6-40 | Coil Outer Diameter LARGE: 6 mm | In distribution |
| CV-4-5 | Coil Outer Diameter: 4.8 mm | In distribution |
| CV-28-40 | Compatible Catheter Inner Diameter: 0.69-1.07 mm | In distribution |
| CV-8-40 | Coil Outer Diameter: 9.6 mm | In distribution |
| CV-24-40 | Implant Outer Diameter: 0.57 mm | In distribution |
| CV-12-30 | Compatible Catheter Inner Diameter: 0.69-1.07 mm | In distribution |
| CV-9-40 | Implant Outer Diameter: 0.57 mm | In distribution |
| CV-7-20 | Coil Length: 20 cm | In distribution |
| CV-5-30 | Implant Outer Diameter: 0.56 mm | In distribution |
| CV-3-5 | Coil Outer Diameter: 3.6 mm | In distribution |
| CV-18-65 | Coil Length: 65 cm | In distribution |
| CV-8-20 | Implant Outer Diameter: 0.57 mm | In distribution |
| CV-16-65 | Coil Outer Diameter: 13.5 mm | In distribution |
| CV-6-20 | Coil Outer Diameter: 7.2 mm | In distribution |
| CV-4-15 | Coil Outer Diameter LARGE: 4 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prestige Coil System | Balt USA, LLC | 339 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 279 |
| Optima Coil System | Balt USA, LLC | 255 |
| AxiumTM | Micro Therapeutics, Inc. | 255 |
| Avenir | Shanghai Wallaby Medical Technologies Co., Inc. | 184 |
| MReye | Cook Incorporated | 167 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 162 |
| Nester | Cook Incorporated | 160 |
| Axium | Micro Therapeutics, Inc. | 146 |
| ConcertoTM | Micro Therapeutics, Inc. | 133 |
| Tornado | Cook Incorporated | 111 |
| V-Trak | MicroVention, Inc. | 105 |
Showing 12 of 158. All products under Device, Vascular, For Promoting Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261866 | 2026-06-24 |
| K253511 | 2026-01-14 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P780011 | 1988-01-29 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.