The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / Short-wire Compatible.
| Device ID | K211021 |
| 510k Number | K211021 |
| Device Name: | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / Short-wire Compatible |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No. 10 Goake Third Road, Nanjig National Hi-Tech Industrial Development Zone Narijing, CN 210032 |
| Contact | Cecilia Sun |
| Correspondent | Becky Li Micro-Tech (Nanjing) Co., Ltd. No. 10 Goake Third Road, Nanjig National Hi-Tech Industrial Development Zone Narijing, CN 210032 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-05 |
| Decision Date | 2022-05-06 |