The following data is part of a premarket notification filed by Guidant Cardiac And Vascular Surgery with the FDA for Evt Marker Board.
| Device ID | K970608 |
| 510k Number | K970608 |
| Device Name: | EVT MARKER BOARD |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GUIDANT CARDIAC AND VASCULAR SURGERY 1360 O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Luanne Termeer |
| Correspondent | Luanne Termeer GUIDANT CARDIAC AND VASCULAR SURGERY 1360 O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-04-21 |
| Summary: | summary |