The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intrastent Doublestrut Xs Stent.
| Device ID | K000864 |
| 510k Number | K000864 |
| Device Name: | INTRASTENT DOUBLESTRUT XS STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Contact | Maria E Brittle |
| Correspondent | Maria E Brittle INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-17 |
| Decision Date | 2000-04-14 |