|
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
|
AVINGER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
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
|
1. K152694 Diamondback 360 Peripheral Orbital Atherectomy Sys ...
|
2. K180416 ViperWire Advance Guide Wire, Stealth 360 Orbital ...
|
3. K182397 Diamondback 360 Peripheral Orbital Atherectomy Sys ...
|
4. K190634 Diamondback 360 Peripheral Orbital Atherectomy Sys ...
|
5. K203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy Sys ...
|
6. K210586 Diamonback 360 Peripheral Orbital Atherectomy Syst ...
|
7. K220109 DIAMONDBACK 360 Peripheral Orbital Atherectomy Sys ...
|
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
|
|
|
|
|