KRD
- Product code
- KRD
- Device name
- Device, Vascular, For Promoting Embolization
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.3300
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 22
- Summaries archived here
- 21 (direct download)
- 510(k) clearances (all years, FDA)
- 132 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (22)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252812 | 2026-07-31 | Suzhou Haowei Medical Technology Co., … | UniPearls® Embolic Microspheres | |
| K261488 | 2026-07-24 | Boston Scientific Corporation | OBSIDIO Conformable Embolic | |
| K261866 | 2026-06-24 | Medtronic, Inc. | Concerto Versa Detachable Coil | |
| K260635 | 2026-06-12 | Nuvascular, Inc. | HARBOR Occlusion Device | |
| K260508 | 2026-04-10 | Okami Medical, Inc. | LOBO Vascular Occlusion System | |
| K253511 | 2026-01-14 | Medtronic, Inc. | Concerto Versa Detachable Coil | |
| K253677 | 2025-12-15 | Instylla, Inc. | Tembo Embolic System | |
| K253376 | 2025-10-30 | Boston Scientific Corporation | OBSIDIO Conformable Embolic (M0013972101010) | |
| K250209 | 2025-09-23 | Canyon Medical, Inc. | Polyvinyl Alcohol Embolic Microspheres | |
| K250133 | 2025-07-09 | Nuvascular, Inc. | HARBOR Occlusion Device | |
| K251383 | 2025-05-30 | Balt USA, LLC | Prestige Coil System (Prestige Packing Line Extensio… | |
| K250971 | 2025-05-16 | Biosphere Medical, S.A. | Embosphere Microspheres | |
| K250276 | 2025-05-15 | Embolization, Inc. | Nitinol Enhanced Device (NED) | |
| K250079 | 2025-03-14 | Penumbra, Inc. | Ruby XL System | |
| K242608 | 2025-01-17 | Varian Medical Systems, Inc. | Embozene Color-Advanced Microspheres | FDA |
| K240873 | 2024-12-16 | Instylla, Inc. | TEMBO Embolic System | |
| K242794 | 2024-10-16 | Varian Medical Systems, Inc. | ONCOZENE Microspheres | |
| K242507 | 2024-10-03 | Boston Scientific | OBSIDIO Conformable Embolic | |
| K232934 | 2024-05-30 | Hangzhou Yangshun Medical Technology C… | Sunsphere | |
| K240261 | 2024-05-02 | Merit Medical Systems, Inc. | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular P… | |
| K234123 | 2024-02-13 | Abk Biomedical, Inc. | Easi-Vue® embolic microspheres System | |
| K231554 | 2023-11-14 | Suzhou Haowei Medical Technology Co., … | UniPearls® Embolic Microspheres |
Official FDA classification page: KRD
Classification and pathway per current FDA publications. Data from openFDA (CC0).