The following data is part of a premarket notification filed by Guidant Cardiac And Vascular Surgery with the FDA for Evt Angioscale Angiographic Catheter.
| Device ID | K970469 |
| 510k Number | K970469 |
| Device Name: | EVT ANGIOSCALE ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-07 |
| Decision Date | 1997-05-08 |
| Summary: | summary |