The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Vanguard Dx Angiographic Catheter.
| Device ID | K050371 |
| 510k Number | K050371 |
| Device Name: | MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Geoff M Fatzinger |
| Correspondent | Geoff M Fatzinger MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-14 |
| Decision Date | 2005-06-07 |
| Summary: | summary |