The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Rx Herculink Plus Biliary Stent System.
| Device ID | K010684 |
| 510k Number | K010684 |
| Device Name: | RX HERCULINK PLUS BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Contact | Byron Lambert |
| Correspondent | Byron Lambert GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-08 |
| Decision Date | 2001-04-12 |