Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K050310 |
Device Name |
BARDPORT TITANIUM PORTS |
Applicant |
BARD ACCESS SYSTEMS, INC. |
5425 WEST AMELIA EARNHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
MICHAELA RIVKOWICH |
Correspondent |
BARD ACCESS SYSTEMS, INC. |
5425 WEST AMELIA EARNHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
MICHAELA RIVKOWICH |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 02/08/2005 |
Decision Date | 04/18/2005 |
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
|
Recalls |
CDRH Recalls
|
|
|