The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Pathfinder-e Roadmapping System.
| Device ID | K922274 |
| 510k Number | K922274 |
| Device Name: | MEDRAD PATHFINDER-E ROADMAPPING SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Jan E Burtick |
| Correspondent | Jan E Burtick MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-14 |
| Decision Date | 1992-10-09 |