Qitexio
Syringe, Piston
Medex
The following data is part of a premarket notification filed by Medex with the FDA for Qitexio.
Pre-market Notification Details
| Device ID | K203738 |
| 510k Number | K203738 |
| Device Name: | Qitexio |
| Classification | Syringe, Piston |
| Applicant | Medex 240 Allée Jacques Monod Saint-Priest, FR 69800 |
| Contact | Sandra Thiolliere |
| Correspondent | Matthew Helmi Guerbet LLC 821 Alexander Road, Suite 204 Princeton, NJ 08540 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-22 |
| Decision Date | 2022-03-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 33700550400746 | K203738 | 000 |
| 33700550400739 | K203738 | 000 |
| 13700550400971 | K203738 | 000 |
Trademark Results [Qitexio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QITEXIO 98721651 not registered Live/Pending |
Guerbet 2024-08-28 |
 QITEXIO 79223561 5543164 Live/Registered |
GUERBET 2017-10-18 |
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