Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K942024 |
Device Name |
PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM |
Applicant |
PHARMACIA DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
LISA J STONE |
Correspondent |
PHARMACIA DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
LISA J STONE |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 04/26/1994 |
Decision Date | 07/26/1994 |
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
|
|
|