The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Reliant(tm) Multistage Dilatation Balloon Catheter.
| Device ID | K180418 |
| 510k Number | K180418 |
| Device Name: | Reliant(TM) Multistage Dilatation Balloon Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
| Contact | Becky Li |
| Correspondent | Becky Li Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing, 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 | 2018-02-15 |
| Decision Date | 2018-10-15 |
| Summary: | summary |