DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
Injector And Syringe, Angiographic
Osprey Medical, Inc.
The following data is part of a premarket notification filed by Osprey Medical, Inc. with the FDA for Dyevert™ Ng Contrast Reduction System, Dyevert™ Plus Ez Contrast Reduction System, Dyetect™ Contrast Monitoring Disposable Kit, Smart Syringe, Dyevert™ Plus Ez Contrast Reduction System.
Pre-market Notification Details
| Device ID | K183267 |
| 510k Number | K183267 |
| Device Name: | DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Osprey Medical, Inc. 5600 Rowland Rd, Suite 250 Minnetonka, MN 55343 |
| Contact | Melanie Hess |
| Correspondent | Melanie Hess Osprey Medical, Inc. 5600 Rowland Rd, Suite 250 Minnetonka, MN 55343 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2018-12-20 |
| Summary: | summary |
Trademark Results [DyeVert]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYEVERT 86698606 4938496 Live/Registered |
Osprey Medical, Inc. 2015-07-20 |
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