KRD — Device, Vascular, For Promoting Embolization Class II
FDA Device Classification
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 |
|---|
| 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 |
| K230706 | boston scientific corporation | EMBOLD Soft Detachable Coil System | June 27, 2023 |
| K223050 | microvention | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880 | December 21, 2022 |
| K220567 | abk biomedical | Easi-Vue embolic microspheres System | September 7, 2022 |