Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular |
||||
---|---|---|---|---|---|
510(k) Number | K960350 | ||||
Device Name | THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 | ||||
Applicant |
|
||||
Applicant Contact | patrick j cooper | ||||
Correspondent |
|
||||
Correspodent Contact | patrick j cooper | ||||
Regulation Number | 880.5965 | ||||
Classification Product Code |
|
||||
Date Received | 01/25/1996 | ||||
Decision Date | 04/15/1996 | ||||
Decision |
substantially equivalent (SESE) |
||||
Regulation Medical Specialty |
General Hospital |
||||
510k Review Panel |
General Hospital |
||||
summary |
summary |
||||
Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |