The following data is part of a premarket notification filed by Suzhou Hengrui Disheng Medical Co.,ltd. with the FDA for Hydrophilic Coating Guide Wire.
| Device ID | K193653 |
| 510k Number | K193653 |
| Device Name: | Hydrophilic Coating Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Suzhou Hengrui Disheng Medical Co.,Ltd. No. 11 Building, No.8 Jinfeng Road Suzhou 215163, CN 215163 |
| Contact | Ling Li |
| Correspondent | Ling Li Suzhou Hengrui Disheng Medical Co.,Ltd. No. 11 Building, No.8 Jinfeng Road Suzhou 215163, CN 215163 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2020-08-26 |