|
Device |
guide, wire, catheter, neurovasculature |
Product Code | MOF |
Regulation Number |
870.1330
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ARTIRIA MEDICAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAHI INTECC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BALT USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO VENTION INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROVENTION INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAPID-MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA VASCULAR INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA VASCULAR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K181828 Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Gu ...
|
2. K183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aris ...
|
SCIENTIA VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA VASCULAR, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|