Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K211021 |
Device Name |
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible |
Applicant |
Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Goake Third Road, Nanjig National Hi-Tech Industrial |
Development Zone |
Narijing,
CN
210032
|
|
Applicant Contact |
Cecilia Sun |
Correspondent |
Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Goake Third Road, Nanjig National Hi-Tech Industrial |
Development Zone |
Narijing,
CN
210032
|
|
Correspondent Contact |
Becky Li |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/05/2021 |
Decision Date | 05/06/2022 |
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
|
|
|