Polyvinyl Alcohol Embolic Microspheres
FDA 510(k) K250209 · Canyon Medical, Inc.
510(k) numberK250209
Submission
- Device name
- Polyvinyl Alcohol Embolic Microspheres
- Applicant
- Canyon Medical, Inc.
Nanjing, CN - Received
- January 24, 2025
- Decision date
- September 23, 2025
- 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 |
| 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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| 510(k) | Device | Decision |
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| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A)NEY · Traditional | 09/26/2024SE |
| K241825 | Microwave Ablation AntennasNEY · Traditional | 09/20/2024SE |
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic…KNW · Traditional | 01/17/2024SE |
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic…KNW · Traditional | 04/03/2023SE |
Questions and answers
When was Polyvinyl Alcohol Embolic Microspheres cleared by the FDA?
Polyvinyl Alcohol Embolic Microspheres (K250209) received a 510(k) decision of Substantially Equivalent on September 23, 2025, 242 days after the submission was received.
What is the product code of K250209?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.