| Device Classification Name |
catheter, percutaneous |
|||
|---|---|---|---|---|
| 510(k) Number | K021120 | |||
| Device Name | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP | |||
| Original Applicant |
|
|||
| Original Contact | debbie peacock | |||
| Regulation Number | 870.1250 | |||
| Classification Product Code |
|
|||
| Date Received | 04/08/2002 | |||
| Decision Date | 05/02/2002 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Cardiovascular |
|||
| summary |
summary |
|||
| Type | Special | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |