Product code KRD
- Device name
- Device, Vascular, For Promoting Embolization
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3300
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P780011S012 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| P780011S011 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| P780011S010 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| P780011S007 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| P780011S006 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-04 |
| P780011S004 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-18 |
| P780011S005 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-11-27 |
| P780011S001 | MINI-BALLOON DETACHABLE BALLOON SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-11-27 |
| P780011S003 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-11-20 |
| P780011 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-05-15 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260508 | LOBO Vascular Occlusion System | Okami Medical, Inc. | 2026-04-10 |
| K253511 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026-01-14 |
| K253677 | Tembo Embolic System | Instylla, Inc. | 2025-12-15 |
| K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | Boston Scientific Corporation | 2025-10-30 |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | 2025-09-23 |
| K250133 | HARBOR Occlusion Device | Nuvascular, Inc. | 2025-07-09 |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | 2025-05-30 |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | 2025-05-16 |
| K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | 2025-05-15 |
| K250079 | Ruby XL System | Penumbra, Inc. | 2025-03-14 |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | 2025-01-17 |
| K240873 | TEMBO Embolic System | Instylla, Inc. | 2024-12-16 |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | 2024-10-16 |
| K242507 | OBSIDIO™ Conformable Embolic | Boston Scientific | 2024-10-03 |
| K232934 | Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd | 2024-05-30 |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | Merit Medical Systems, Inc. | 2024-05-02 |
| K234123 | Easi-Vue® embolic microspheres System | Abk Biomedical, Inc. | 2024-02-13 |
| K231554 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2023-11-14 |
| K230706 | EMBOLD™ Soft Detachable Coil System | Boston Scientific Corporation | 2023-06-27 |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | MicroVention, Inc. | 2022-12-21 |
| K220567 | Easi-Vue embolic microspheres System | Abk Biomedical, Inc. | 2022-09-07 |
| K213385 | GEM | Obsidio, Inc. | 2022-07-01 |
| K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | Okami Medical | 2022-04-29 |
| K213398 | EMBOLD Fibered Detachable Coil System | Boston Scientific Corporation | 2022-04-12 |
| K220699 | Prestige Coil System | Bait USA, LLC | 2022-04-08 |
| K213200 | Solus Gold Embolization Device | Artio Medical, Inc. | 2022-03-21 |
| K212057 | Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS | Artventive Medical Group, Inc. | 2022-03-01 |
| K212817 | Merit Siege Vascular Plug | Merit Medical System, Inc. | 2021-12-15 |
| K210562 | HRSpheres Narrow-Size Embolic Microspheres | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2021-10-01 |
| K202850 | Concerto Versa, Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-02-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000488192 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488000 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000489137 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000489076 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000489052 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488994 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488864 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488017 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488239 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488727 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488932 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488260 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00847536033368 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-29 |
| 00847536033306 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-29 |
| 00847536030008 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536034372 | Axium PrimeTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536034358 | Axium PrimeTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536034310 | Axium PrimeTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536034242 | Axium PrimeTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536030138 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536030077 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029668 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029996 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029965 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029941 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029910 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029866 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029842 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029781 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029729 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |