The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intracoil Stent.
| Device ID | K001257 |
| 510k Number | K001257 |
| Device Name: | INTRACOIL STENT |
| Classification | Prosthesis, Tracheal, Expandable |
| 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 | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-19 |
| Decision Date | 2000-05-18 |