|
Device |
device, vascular, for promoting embolization |
Product Code | KRD |
Regulation Number |
870.3300
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABK BIOMEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTIO MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTVENTIVE MEDICAL GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAIT USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSPHERE MEDICAL, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
C. R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMBOLIC ACCELERATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU YANGSHUN MEDICAL TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROVENTION INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OBSIDIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OKAMI MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHAPE MEMORY MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2019 |
1185 |
1185 |
2020 |
1167 |
1167 |
2021 |
1444 |
1444 |
2022 |
1498 |
1498 |
2023 |
1374 |
1374 |
2024 |
1040 |
1040 |
|
|
|
|