|
|
| Device |
catheter, thrombus retriever |
| Definition |
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode. |
| Product Code | NRY |
| Regulation Number |
870.1250
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ALEMBIC, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| BALT USA, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CERENOVUS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| CODMAN & SHURTLEFF, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| IMPERATIVE CARE INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| INNEUROCO, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MICROVENTION INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NEURAVI LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| NEURAVI, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PENUMBRA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
8
|
| PERFUZE LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| Q'APEL MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| RAPID MEDICAL LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| ROUTE 92 MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SCIENTIA VASCULAR INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| STRYKER |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| STRYKER NEUROVASCULAR |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| WALLABY MEDICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|
