Device Classification Name |
catheter, hemodialysis, implanted
|
510(k) Number |
K060972 |
Device Name |
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) |
Applicant |
KENDALL |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
KEITH MARTIN |
Correspondent |
KENDALL |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
KEITH MARTIN |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 04/07/2006 |
Decision Date | 08/04/2006 |
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 |
Yes
|
Recalls |
CDRH Recalls
|
|
|