Device Classification Name |
Catheter, Hemodialysis, Implanted
|
510(k) Number |
K121933 |
Device Name |
NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) |
Applicant |
MARVAO MEDICAL DEVICES, LTD. |
368 WEST MAIN STREET |
SUITE 7 |
NORTHBOROUGH,
MA
01532
|
|
Applicant Contact |
Marybeth Gamber |
Correspondent |
MARVAO MEDICAL DEVICES, LTD. |
368 WEST MAIN STREET |
SUITE 7 |
NORTHBOROUGH,
MA
01532
|
|
Correspondent Contact |
Marybeth Gamber |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 03/14/2013 |
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
|
|
|