The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Mark 7 Arterion (pedestal System), (table Mount System), Medrad Mark 7 Arterion Arterion Syringe.
| Device ID | K113133 |
| 510k Number | K113133 |
| Device Name: | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DRIVE Indianola, PA 15051 |
| Contact | Mike Burnside |
| Correspondent | Mike Burnside MEDRAD, INC. ONE MEDRAD DRIVE Indianola, PA 15051 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2011-12-15 |
| Summary: | summary |