Concerto Detachable Coil System
FDA 510(k) K090046 · Micro Therapeutics, Inc.
510(k) numberK090046
Submission
- Device name
- Concerto Detachable Coil System
- Applicant
- Micro Therapeutics, Inc.
Irvine, CA, US - Received
- January 7, 2009
- Decision date
- February 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K113289 | Orion Micro CatheterKRA · Traditional | 08/01/2012SE |
| K113454 | 14 Wire Standard, 14 Wire LSDQX · Traditional | 02/24/2012SE |
| K090870 | Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and…KRA · Special | 05/01/2009SE |
| K081465 | Axium Detachable Coil SystemKRD · Traditional | 08/19/2008SE |
| K060747 | FX Detachable Coil SystemHCG · Traditional | 04/24/2007SE |
| K060625 | Nexus Detachable Coil System, Morpheus 3D CSRHCG · Special | 04/20/2006SE |
| K051990 | Echelon Micro CatheterKRA · Traditional | 01/04/2006SE |
| K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRHCG · Special | 06/28/2005SE |
| K051425 | Nexus Detachable Coil System, Helix Super Soft CSRHCG · Special | 06/22/2005SE |
| K050543 | Nexus Detachable Coil SystemHCG · Traditional | 04/27/2005SE |
Questions and answers
When was Concerto Detachable Coil System cleared by the FDA?
Concerto Detachable Coil System (K090046) received a 510(k) decision of Substantially Equivalent on February 27, 2009, 51 days after the submission was received.
What is the product code of K090046?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.