|
Device |
catheter, peripheral, atherectomy |
Product Code | MCW |
Regulation Number |
870.4875
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ATHEROMED INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AVINGER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K152275 Pantheris System
|
2. K153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
|
3. K160827 Pantheris Catheter
|
4. K163264 Pantheris Catheter (8F); Pantheris Cather (7F); Li ...
|
5. K172236 Pantheris Catheter (8F), Pantheris Catheter (7F), ...
|
6. K173862 Pantheris System
|
7. K182341 Pantheris SV
|
8. K212047 Pantheris System
|
9. K230005 Pantheris LV Atherectomy Catheter
|
AVINGER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
1. K152275 Pantheris System
|
2. K153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
|
3. K160827 Pantheris Catheter
|
4. K163264 Pantheris Catheter (8F); Pantheris Cather (7F); Li ...
|
5. K172236 Pantheris Catheter (8F), Pantheris Catheter (7F), ...
|
6. K173862 Pantheris System
|
7. K182341 Pantheris SV
|
8. K212047 Pantheris System
|
9. K230005 Pantheris LV Atherectomy Catheter
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIO FLOW INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIO FLOW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIO SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOVASCUALR SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOVASCULAR SYSTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOVASCULAR SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
CARDIOVASCULAR SYSTEMS INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOVASCULAR SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
COVIDIEN, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EV3 INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EXIMO MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
EXIMO MEDICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDRAD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PATHWAY MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
REX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
REX MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPECTRANETICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPECTRANETICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRANETICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRANETICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
STRAUB MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOLCANO ATHEROMED INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOLCANO ATHEROMED INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VOLCANO ATHEROMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
|
|
|