Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K133335 |
Device Name |
POWERPORT IMPLANTABLE PORT |
Applicant |
C.R. BARD, INC. |
605 N 5600 W |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
AMY HONEY |
Correspondent |
C.R. BARD, INC. |
605 N 5600 W |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
AMY HONEY |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 10/29/2013 |
Decision Date | 02/14/2014 |
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
|
|
|