The following data is part of a premarket notification filed by Medrad, Inc. / Bayer Medical Care, Inc. with the FDA for Medrad Mark 7 Arterion Injection System / Syringe, Twist & Go Syringe.
| Device ID | K132928 |
| 510k Number | K132928 |
| Device Name: | MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. / BAYER MEDICAL CARE, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Lisa A Ewing |
| Correspondent | Lisa A Ewing MEDRAD, INC. / BAYER MEDICAL CARE, 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 | 2013-09-18 |
| Decision Date | 2014-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10616258006991 | K132928 | 000 |
| 40616258020165 | K132928 | 000 |
| 40616258021643 | K132928 | 000 |