Device Classification Name |
Set, Administration, For Peritoneal Dialysis, Disposable
|
510(k) Number |
K192705 |
Device Name |
MiniCap Extended Life PD Transfer Sets |
Applicant |
Baxter Healthcare |
32650 N. Wilson Road |
Round Lake,
IL
60073
|
|
Applicant Contact |
Kimberly Garcia |
Correspondent |
Baxter Healthcare |
32650 N. Wilson Road |
Round Lake,
IL
60073
|
|
Correspondent Contact |
Kimberly Garcia |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 09/27/2019 |
Decision Date | 10/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|