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 Syringe.
| Device ID | K112086 |
| 510k Number | K112086 |
| Device Name: | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Mike Burnside |
| Correspondent | Mike Burnside MEDRAD, INC. ONE MEDRAD DR. 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 | 2011-07-21 |
| Decision Date | 2011-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258021362 | K112086 | 000 |
| 40616258021636 | K112086 | 000 |
| 40616258021629 | K112086 | 000 |
| 00616258022406 | K112086 | 000 |
| 00616258025339 | K112086 | 000 |
| 00616258025322 | K112086 | 000 |
| 00616258025315 | K112086 | 000 |
| 00616258025308 | K112086 | 000 |
| 40616258024781 | K112086 | 000 |
| 10616258005543 | K112086 | 000 |
| 10616258007080 | K112086 | 000 |
| 00616258020495 | K112086 | 000 |
| 00616258010069 | K112086 | 000 |
| 00616258009384 | K112086 | 000 |
| 00616258009377 | K112086 | 000 |
| 00616258009360 | K112086 | 000 |
| 00616258009353 | K112086 | 000 |
| 00616258009346 | K112086 | 000 |
| 10616258007844 | K112086 | 000 |
| 40616258024354 | K112086 | 000 |