The following data is part of a premarket notification filed by Osprey Medical, Inc. with the FDA for Avert Contrast Modulation System.
| Device ID | K150485 |
| 510k Number | K150485 |
| Device Name: | AVERT Contrast Modulation System |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Osprey Medical, Inc. 5600 Rowland Road, Suite 250 Minnetonka, MN 55343 |
| Contact | Melanie Hess |
| Correspondent | Melanie Hess Osprey Medical, Inc. 5600 Rowland Road, 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 | 2015-02-24 |
| Decision Date | 2015-03-26 |
| Summary: | summary |