| Device Classification Name |
catheter, percutaneous |
|||
|---|---|---|---|---|
| 510(k) Number | K131492 | |||
| Device Name | MODIFIED FLOWGATE BALLOON GUIDE CATHETER | |||
| Applicant |
|
|||
| Applicant Contact | rhoda santos | |||
| Correspondent |
|
|||
| Correspodent Contact | rhoda santos | |||
| Regulation Number | 870.1250 | |||
| Classification Product Code |
|
|||
| Date Received | 05/23/2013 | |||
| Decision Date | 10/03/2013 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Neurology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Clinical Trials | NCT00318071 | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |