The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Bard E Luminexx Biliary Stent.
| Device ID | K063532 |
| 510k Number | K063532 |
| Device Name: | BARD E LUMINEXX BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BARD PERIPHERAL VASCULAR, INC. P.O. BOX 1740 Tempe, AZ 85280 -1740 |
| Contact | Lindsay K Pack |
| Correspondent | Lindsay K Pack BARD PERIPHERAL VASCULAR, INC. P.O. BOX 1740 Tempe, AZ 85280 -1740 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-22 |
| Decision Date | 2008-05-30 |
| Summary: | summary |