The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Stellant Ct Injector System With P3t.
| Device ID | K072886 |
| 510k Number | K072886 |
| Device Name: | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Lisa M Casavant |
| Correspondent | Lisa M Casavant MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-09 |
| Decision Date | 2007-12-21 |
| Summary: | summary |