The following data is part of a premarket notification filed by Suzhou Hengrui Disheng Medical Co.,ltd. with the FDA for Microcatheter And Guide-wire System.
| Device ID | K171665 |
| 510k Number | K171665 |
| Device Name: | Microcatheter And Guide-wire System |
| Classification | Catheter, Continuous Flush |
| Applicant | Suzhou Hengrui Disheng Medical Co.,Ltd. No. 11 Building, No.8 Jinfeng Road Suzhou 215163, CN 215163 |
| Contact | Jingwen Li |
| Correspondent | Jingwen Li Suzhou Hengrui Disheng Medical Co.,Ltd. No. 11 Building, No.8 Jinfeng Road Suzhou 215163, CN 215163 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-05 |
| Decision Date | 2018-01-11 |
| Summary: | summary |