The following data is part of a premarket notification filed by Medtronic Ave, Inc. with the FDA for Medtronic Ave Bridge Polaris Biliary Stent System (polaris).
| Device ID | K022026 |
| 510k Number | K022026 |
| Device Name: | MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDTRONIC AVE, INC. 2170-A NORTHPOINT PRKWY Santa Rosa, CA 95407 |
| Contact | Kevin Drisko |
| Correspondent | Kevin Drisko MEDTRONIC AVE, INC. 2170-A NORTHPOINT PRKWY Santa Rosa, CA 95407 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-21 |
| Decision Date | 2002-07-19 |
| Summary: | summary |