The following data is part of a premarket notification filed by Medtronic Ave, Inc. with the FDA for Bridge Se Self-expanding Stent Delivery System.
| Device ID | K011080 |
| 510k Number | K011080 |
| Device Name: | BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDTRONIC AVE, INC. 2170 NORTHPOINT PKWY. Santa Rosa, CA 95407 |
| Contact | John Riolo |
| Correspondent | John Riolo MEDTRONIC AVE, INC. 2170 NORTHPOINT PKWY. Santa Rosa, CA 95407 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-09 |
| Decision Date | 2001-10-11 |