The following data is part of a premarket notification filed by Guidant Cardiac And Vascular Surgery with the FDA for Evt Expandable Sheath.
| Device ID | K970470 |
| 510k Number | K970470 |
| Device Name: | EVT EXPANDABLE SHEATH |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| 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 | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-07 |
| Decision Date | 1997-07-31 |