|
Device |
injector and syringe, angiographic |
Regulation Description |
Angiographic injector and syringe. |
Product Code | DXT |
Regulation Number |
870.1650
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACIST MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K191060 ACIST CVI1 Contrast Delivery System, A1000 Syringe ...
|
2. K203004 ACIST CVi1 Contrast Delivery System, ACIST CVi Con ...
|
BAYER MEDICAL CARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYER MEDICAL CARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEMOTO KYORINDO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO DIZEGENS MEDICAL SCIENCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSPREY MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION MEDICAL PLASTICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG INT MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BOON MEDICAL SUPPLY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN BOON MEDICAL SUPPLY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YOUWO (GUANGZHOU) MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|