The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Bard Conformexx Biliary Stent With The Performaxx Grip.
| Device ID | K052114 |
| 510k Number | K052114 |
| Device Name: | BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BARD PERIPHERAL VASCULAR, INC. P.O. BOX 1740 Tempe, AZ 85280 -1740 |
| Contact | Dennis Salzmann |
| Correspondent | Dennis Salzmann 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-04 |
| Decision Date | 2005-08-25 |
| Summary: | summary |