Device Classification Name |
Catheter, Percutaneous, Neurovasculature
|
510(k) Number |
K212288 |
Device Name |
Minjie Catheter System |
Applicant |
Kai Medtech, LLC |
22651 Lambert Street, Suite 107 |
Lake Forest,
CA
92630
|
|
Applicant Contact |
Stephanie Rallis |
Correspondent |
Kai Medtech, LLC |
22651 Lambert Street, Suite 107 |
Lake Forest,
CA
92630
|
|
Correspondent Contact |
Ricardo Olivo |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2021 |
Decision Date | 06/02/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|