Concerto Versa, Detachable Coil
FDA 510(k) K202850 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
510(k) numberK202850
Submission
- Device name
- Concerto Versa, Detachable Coil
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA, US - Received
- September 28, 2020
- Decision date
- February 9, 2021
- 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 |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| 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 |
More from Nuvascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…QJP · Special | 01/02/2025SE |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special | 12/02/2024SE |
| K243080 | Riptide Aspiration SystemNRY · Special | 10/29/2024SE |
| K211990 | Rist 071 Radial Access Guide CatheterDQY · Special | 07/27/2021SE |
| K203432 | Axium Detachable Coil; Axium Prime Detachable CoilHCG · Traditional | 07/07/2021SE |
| K203358 | Solitaire X Revascularization DevicePOL · Traditional | 03/01/2021SE |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…POL · Traditional | 11/20/2020SE |
| K202318 | Marathon Flow Directed Micro CatheterKRA · Special | 09/14/2020SE |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireDQX · Special | 07/21/2020SE |
| K201689 | Riptide Aspiration SystemNRY · Special | 07/21/2020SE |
Questions and answers
When was Concerto Versa, Detachable Coil cleared by the FDA?
Concerto Versa, Detachable Coil (K202850) received a 510(k) decision of Substantially Equivalent on February 9, 2021, 134 days after the submission was received.
What is the product code of K202850?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.