The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intrastent Doublestrut Paramount Xs Biliary Endoprosthesis.
| Device ID | K003997 |
| 510k Number | K003997 |
| Device Name: | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-01-24 |