| Device Classification Name |
catheter, percutaneous |
|||
|---|---|---|---|---|
| 510(k) Number | K131482 | |||
| Device Name | SOFIA DISTAL ACCESS CATHETER | |||
| Applicant |
|
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| Applicant Contact | naomi gong | |||
| Correspondent |
|
|||
| Correspodent Contact | naomi gong | |||
| Regulation Number | 870.1250 | |||
| Classification Product Code |
|
|||
| Subsequent Product Code |
|
|||
| Date Received | 05/23/2013 | |||
| Decision Date | 11/22/2013 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Neurology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |