Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K034065 |
Device Name |
MODIFICATION TO X-PORT DUO PORT |
Applicant |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
ANGELA BRADY |
Correspondent |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
ANGELA BRADY |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 12/29/2003 |
Decision Date | 01/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|