|
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
|
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
|
1. K083489 JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV1 ...
|
2. K083837 JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 ...
|
3. K090325 JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 ...
|
4. K091509 JETSTREAM G2 NXT SYSTEM, MODEL PV20300
|
5. K092332 JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 ...
|
6. K093456 JETSTREAM G3 SYSTEM
|
7. K093918 JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 ...
|
8. K100462 JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, ...
|
9. K101221 JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MO ...
|
10. K101334 JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MOD ...
|
11. K110626 JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; ...
|
12. K111229 JETSTREAM G3 (R) SF 1.6 SYSTEM
|
13. K120242 JETSTREAM NAVITUS L SYSTEM
|
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
|
|
|
|
|