Device Classification Name |
system, perfusion, kidney
|
510(k) Number |
K211333 |
Device Name |
KIDNEY ASSIST-transport |
Applicant |
XVIVO Perfusion AB |
Mässans Gata 10 |
Goteborg,
SE
41251
|
|
Applicant Contact |
Arjan van der Plaats |
Correspondent |
Medical Device Approvals, Inc. |
104 E. Harrison Ave. |
Fairfield,
IA
52556
|
|
Correspondent Contact |
Kathleen Johnson |
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 05/03/2021 |
Decision Date | 01/20/2022 |
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
|
|
|