Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K926011 |
Device Name |
A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI |
Applicant |
THEREX CORP. |
1600 PROVIDENCE HIGHWAY |
WALPOLE,
MA
02081
|
|
Applicant Contact |
BRADLEY J ENEGREN |
Correspondent |
THEREX CORP. |
1600 PROVIDENCE HIGHWAY |
WALPOLE,
MA
02081
|
|
Correspondent Contact |
BRADLEY J ENEGREN |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 11/16/1992 |
Decision Date | 03/19/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|