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 |