The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Modification To Rx Herculink Elite Biliary Stent System.
| Device ID | K063481 |
| 510k Number | K063481 |
| Device Name: | MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Nadine Smith |
| Correspondent | Nadine Smith ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2007-09-14 |
| Summary: | summary |