Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K033686 |
Device Name |
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM |
Applicant |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX ROAD |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
PATRICIA A LAFORTE |
Correspondent |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX ROAD |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
PATRICIA A LAFORTE |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 11/24/2003 |
Decision Date | 01/23/2004 |
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
|
|
|