Device Classification Name |
Catheter, Hemodialysis, Non-Implanted
|
510(k) Number |
K153190 |
Device Name |
Zenysis Short-Term Dialysis Catheter |
Applicant |
C.R BARD INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
SILVIA DE LA BARRA |
Correspondent |
C.R BARD INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
SILVIA DE LA BARRA |
Regulation Number | 876.5540 |
Classification Product Code |
|
Date Received | 11/03/2015 |
Decision Date | 01/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|