The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intrastent Ii.
| Device ID | K990592 |
| 510k Number | K990592 |
| Device Name: | INTRASTENT II |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Contact | Cathy Yohnk |
| Correspondent | Cathy Yohnk INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-24 |
| Decision Date | 1999-09-01 |