|
Device |
catheter, continuous flush |
Product Code | KRA |
Regulation Number |
870.1210
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABLATIVE SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGILE DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARGON MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BALT USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEND IT TECHNOLOGIES LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS MEDICAL COMPONENTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTYLLA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERCATOR MEDSYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICRO THERAPEUATICS, INC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMARTWISE SWEDEN AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANSIT SCIENTIFIC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRISALUS LIFE SCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VASCUPATENT MEDICAL (SHENZHEN) CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VVT MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WALLABY MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|