The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Stellant Ct Injector System With P3t Cardiac.
| Device ID | K082905 |
| 510k Number | K082905 |
| Device Name: | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Fortunato Aldape |
| Correspondent | Fortunato Aldape 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 | 2008-09-30 |
| Decision Date | 2009-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258021331 | K082905 | 000 |
| 00616258020860 | K082905 | 000 |
| 00616258008448 | K082905 | 000 |
| 00616258008455 | K082905 | 000 |
| 00616258008462 | K082905 | 000 |
| 00616258008479 | K082905 | 000 |
| 00616258008486 | K082905 | 000 |
| 00616258008493 | K082905 | 000 |
| 00616258008943 | K082905 | 000 |
| 00616258009766 | K082905 | 000 |
| 00616258020822 | K082905 | 000 |