Device Classification Name |
catheter, hemodialysis, implanted
|
510(k) Number |
K111117 |
Device Name |
CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... |
Applicant |
Teleflex Medical, Inc. |
2400 BERNVILLE ROAD |
READING,
PA
19605
|
|
Applicant Contact |
SUZANNE SCHORLE |
Correspondent |
Teleflex Medical, Inc. |
2400 BERNVILLE ROAD |
READING,
PA
19605
|
|
Correspondent Contact |
SUZANNE SCHORLE |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 04/21/2011 |
Decision Date | 06/30/2011 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|