The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Ct Custom Convenience Kit.
| Device ID | K933908 |
| 510k Number | K933908 |
| Device Name: | MEDRAD CT CUSTOM CONVENIENCE KIT |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Sandra A Pavlovic |
| Correspondent | Sandra A Pavlovic MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-11 |
| Decision Date | 1994-02-25 |