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 |
|---|---|---|---|
| K252812 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | 2026-07-24 |
| K261866 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026-06-24 |
| K260635 | HARBOR Occlusion Device | Nuvascular, Inc. | 2026-06-12 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886704030355 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030492 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030485 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030478 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030461 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030454 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030447 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030430 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030423 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030416 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030409 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030393 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030386 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030379 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030362 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030188 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030348 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030331 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030324 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030300 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030294 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030287 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030270 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030263 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030256 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030249 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030225 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030218 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030201 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |
| 10886704030195 | ORBIT GALAXY | Medos International Sàrl | 2015-09-20 |