The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Mark V-plus Injector.
| Device ID | K903390 |
| 510k Number | K903390 |
| Device Name: | MEDRAD MARK V-PLUS INJECTOR |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Francis Dobscha |
| Correspondent | Francis Dobscha 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 | 1990-07-27 |
| Decision Date | 1990-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258020808 | K903390 | 000 |
| 00616258010496 | K903390 | 000 |
| 00616258010489 | K903390 | 000 |
| 00616258010465 | K903390 | 000 |
| 00616258010458 | K903390 | 000 |
| 00616258010434 | K903390 | 000 |
| 10801741067690 | K903390 | 000 |
| 40616258010043 | K903390 | 000 |
| 40616258009924 | K903390 | 000 |