|
|
| Device |
catheter, angioplasty, peripheral, transluminal |
| Product Code | LIT |
| Regulation Number |
870.1250
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ABBOTT VASCULAR |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BARD PERIPHERAL VASCULAR, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BIOTRONIK, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| BOSTON SCIENTIFIC CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BROSMED MEDICAL CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| C.R. BARD, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CONTEGO MEDICAL INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CORDIS CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| CORDIS US CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CREAGH MEDICAL LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CREAGH MEDICAL LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS, |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DK MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| INFINITY ANGIOPLASTY BALLOON COMPANY, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| KOSSEL MEDTECH (SUZHOU) CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| KOSSEL MEDTECH (SUZHOU) CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN LLC) |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDTRONIC, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDTRONIC, INC. (FORMERLY D.B.A. EV3 INC, COVIDIEN LLC.) |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MERIT MEDICAL SYSTEMS INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NATEC MEDICAL LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NEXSTEP MEDICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NIPRO MEDICAL CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| QUALIMED USA, LLC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SILK ROAD MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SUMMA THERAPEUTICS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|
