The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Mct, Mct Plus Injector/medrad Front Load.
| Device ID | K924116 |
| 510k Number | K924116 |
| Device Name: | MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Philip B Jarvi |
| Correspondent | Philip B Jarvi 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 | 1992-08-14 |
| Decision Date | 1993-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258010502 | K924116 | 000 |
| 00616258010090 | K924116 | 000 |
| 40616258010104 | K924116 | 000 |
| 00616258005430 | K924116 | 000 |
| 00616258005492 | K924116 | 000 |
| 00616258005508 | K924116 | 000 |
| 10616258007233 | K924116 | 000 |
| 10616258007240 | K924116 | 000 |
| 10616258007264 | K924116 | 000 |
| 00616258007366 | K924116 | 000 |
| 10616258007523 | K924116 | 000 |
| 00616258007793 | K924116 | 000 |
| 00616258010441 | K924116 | 000 |
| 40616258010081 | K924116 | 000 |