Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K090512 |
Device Name |
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER |
Applicant |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
ANGELA M BRADY |
Correspondent |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
ANGELA M BRADY |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 02/26/2009 |
Decision Date | 03/27/2009 |
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
|
|
|