Device Classification Name |
Catheter, Hemodialysis, Implanted
|
510(k) Number |
K062671 |
Device Name |
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) |
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 | 09/08/2006 |
Decision Date | 11/03/2006 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|