The following data is part of a premarket notification filed by Suzhou Innomed Medical Device Co.,ltd with the FDA for Inno-hydrowire.
| Device ID | K172187 |
| 510k Number | K172187 |
| Device Name: | Inno-Hydrowire |
| Classification | Wire, Guide, Catheter |
| Applicant | Suzhou Innomed Medical Device Co.,Ltd 218 Xinghu St., #B1-404 Suzhou, CN 215123 |
| Contact | Jimmy Li |
| Correspondent | Darlene Garner Suzhou Innomed Medical Device Co.,Ltd 113 Garner Cove Georgetown, TX 78633 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-20 |
| Decision Date | 2018-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971564430156 | K172187 | 000 |
| 16971564430118 | K172187 | 000 |
| 06971564430395 | K172187 | 000 |