The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Disposable Multistage Dilation Balloon Catheter.
| Device ID | K151671 |
| 510k Number | K151671 |
| Device Name: | Disposable Multistage Dilation Balloon Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MICRO-TECH (NANJING) CO., LTD. NO.10 GAOKE THIRD, NANJING NATIONAL HI-TECH INDUSTRIAL DEVELOPMENT ZONE Nanjing, CN 210032 |
| Contact | Beck Li |
| Correspondent | Becky Li MICRO-TECH (NANJING) CO., LTD. NO.10 GAOKE THIRD, NANJING NATIONAL HI-TECH INDUSTRIAL DEVELOPMENT ZONE 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 | 2015-06-22 |
| Decision Date | 2015-10-16 |
| Summary: | summary |