The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Stellant Ct Injector System With Xds Accessory.
| Device ID | K063090 |
| 510k Number | K063090 |
| Device Name: | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Troy A Jack |
| Correspondent | Troy A Jack MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2007-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258008189 | K063090 | 000 |
| 00616258008172 | K063090 | 000 |