Inno-Pathwire
Wire, Guide, Catheter
Suzhou Innomed Medical Device Co.,Ltd
The following data is part of a premarket notification filed by Suzhou Innomed Medical Device Co.,ltd with the FDA for Inno-pathwire.
Pre-market Notification Details
| Device ID | K182553 |
| 510k Number | K182553 |
| Device Name: | Inno-Pathwire |
| Classification | Wire, Guide, Catheter |
| Applicant | Suzhou Innomed Medical Device Co.,Ltd 218 Xinghu St., #B1-404 Suzhou, CN 215123 |
| Contact | Irene Ding |
| Correspondent | Darlene Garner Darlene Garner 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 | 2018-09-17 |
| Decision Date | 2019-03-11 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971564430217 | K182553 | 000 |
| 16971564430200 | K182553 | 000 |
| 06971564432382 | K182553 | 000 |
Trademark Results [Inno-Pathwire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INNO-PATHWIRE 79256249 not registered Live/Pending |
Suzhou Innomed Medical Device Co., Ltd. 2018-12-28 |
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