The following data is part of a premarket notification filed by Guidant Cardiac And Vascular Surgery with the FDA for Endovance Dualpass Tear-away Sheath Introducer.
| Device ID | K002676 |
| 510k Number | K002676 |
| Device Name: | ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | GUIDANT CARDIAC AND VASCULAR SURGERY 1525 O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Kristen Honl |
| Correspondent | Kristen Honl GUIDANT CARDIAC AND VASCULAR SURGERY 1525 O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-28 |
| Decision Date | 2000-10-30 |