Device Classification Name |
catheter, hemodialysis, triple lumen, non-implanted
|
510(k) Number |
K133456 |
Device Name |
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER |
Applicant |
C.R. BARD, INC. |
605 N 5600 W |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
ELIZABETH PETERSON |
Correspondent |
C.R. BARD, INC. |
605 N 5600 W |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
ELIZABETH PETERSON |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 11/12/2013 |
Decision Date | 09/24/2014 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|