KRD · Device, Vascular, For Promoting Embolization
Cardiovascular · 21 CFR 870.3300 · Class 2
Overview
| Product Code | KRD |
|---|---|
| Device Name | Device, Vascular, For Promoting Embolization |
| Regulation | 21 CFR 870.3300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.
Classification Rationale
Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
Recent Cleared Devices (20 of 129)
Showing 20 most recent of 129 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260508 | LOBO Vascular Occlusion System | Okami Medical, Inc. | Apr 10, 2026 | SESE |
| K253511 | Concerto Versa Detachable Coil | Medtronic, Inc. | Jan 14, 2026 | SESE |
| K253677 | Tembo Embolic System | Instylla, Inc. | Dec 15, 2025 | SESE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010) | Boston Scientific Corporation | Oct 30, 2025 | SESE |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | Sep 23, 2025 | SESE |
| K250133 | HARBOR Occlusion Device | Nuvascular, Inc. | Jul 9, 2025 | SESE |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | May 30, 2025 | SESE |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | May 16, 2025 | SESE |
| K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | May 15, 2025 | SESE |
| K250079 | Ruby XL System | Penumbra, Inc. | Mar 14, 2025 | SESE |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | Jan 17, 2025 | SESE |
| K240873 | TEMBO Embolic System | Instylla, Inc. | Dec 16, 2024 | SESE |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | Oct 16, 2024 | SESE |
| K242507 | OBSIDIO Conformable Embolic | Boston Scientific | Oct 3, 2024 | SESE |
| K232934 | Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd | May 30, 2024 | SESE |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | Merit Medical Systems, Inc. | May 2, 2024 | SESE |
| K234123 | Easi-Vue® embolic microspheres System | Abk Biomedical, Inc. | Feb 13, 2024 | SESE |
| K231554 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | Nov 14, 2023 | SESE |
| K230706 | EMBOLD Soft Detachable Coil System | Boston Scientific Corporation | Jun 27, 2023 | SESE |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | MicroVention, Inc. | Dec 21, 2022 | SESE |
Top Applicants
- MicroVention, Inc. — 18 clearances
- Biosphere Medical, S.A. — 9 clearances
- Boston Scientific Corp — 7 clearances
- Cook, Inc. — 7 clearances
- Boston Scientific Corporation — 6 clearances
