Device Classification Name |
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
|
510(k) Number |
K200173 |
Device Name |
Stone Retrieval Balloon |
Applicant |
Hangzhou AGS MedTech Co., Ltd. |
Building 5, Building 6, No.597 Kangxin Road Yuhang District |
Hangzhou,
CN
311106
|
|
Applicant Contact |
Chunqi Han |
Correspondent |
Hangzhou AGS MedTech Co., Ltd. |
Building 5, Building 6, No.597 Kangxin Road Yuhang District |
Hangzhou,
CN
311106
|
|
Correspondent Contact |
Chunqi Han |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 01/23/2020 |
Decision Date | 05/01/2020 |
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
|
|
|