KRD — Device, Vascular, For Promoting Embolization Class II
FDA product code KRD covers "Device, Vascular, For Promoting Embolization", a Class II medical device regulated under 21 CFR 870.3300. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRD
- Device Class
- Class II
- Regulation Number
- 870.3300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261866 | medtronic | Concerto Versa Detachable Coil | June 24, 2026 |
| K260635 | nuvascular | HARBOR Occlusion Device | June 12, 2026 |
| K260508 | okami medical | LOBO Vascular Occlusion System | April 10, 2026 |
| K253511 | medtronic | Concerto Versa Detachable Coil | January 14, 2026 |
| K253677 | instylla | Tembo Embolic System | December 15, 2025 |
| K253376 | boston scientific corporation | OBSIDIO Conformable Embolic (M0013972101010) | October 30, 2025 |
| K250209 | canyon medical | Polyvinyl Alcohol Embolic Microspheres | September 23, 2025 |
| K250133 | nuvascular | HARBOR Occlusion Device | July 9, 2025 |
| K251383 | balt usa | Prestige Coil System (Prestige Packing Line Extension) | May 30, 2025 |
| K250971 | biosphere medical | Embosphere Microspheres | May 16, 2025 |
| K250276 | embolization | Nitinol Enhanced Device (NED) | May 15, 2025 |
| K250079 | penumbra | Ruby XL System | March 14, 2025 |
| K242608 | varian medical systems | Embozene Color-Advanced Microspheres | January 17, 2025 |
| K240873 | instylla | TEMBO Embolic System | December 16, 2024 |
| K242794 | varian medical systems | ONCOZENE Microspheres | October 16, 2024 |
| K242507 | boston scientific | OBSIDIO Conformable Embolic | October 3, 2024 |
| K232934 | hangzhou yangshun medical technology co | Sunsphere | May 30, 2024 |
| K240261 | merit medical systems | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vasc | May 2, 2024 |
| K234123 | abk biomedical | Easi-Vue® embolic microspheres System | February 13, 2024 |
| K231554 | suzhou haowei medical technology co | UniPearls® Embolic Microspheres | November 14, 2023 |