The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Pathfinder Hr Roadmapping System.
| Device ID | K914366 |
| 510k Number | K914366 |
| Device Name: | MEDRAD PATHFINDER HR ROADMAPPING SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Jan E.burtik |
| Correspondent | Jan E.burtik MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1992-02-27 |