The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Rx Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18.
| Device ID | K990867 |
| 510k Number | K990867 |
| Device Name: | RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
| Contact | Sandra Sundell |
| Correspondent | Sandra Sundell ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-16 |
| Decision Date | 1999-09-02 |
| Summary: | summary |