The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intracoil Peripheral Stent.
| Device ID | K990221 |
| 510k Number | K990221 |
| Device Name: | INTRACOIL PERIPHERAL STENT |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | INTRATHERAPEUTICS, INC. 6271 BURY DR. Eden Prairie, MN 55346 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson INTRATHERAPEUTICS, INC. 6271 BURY DR. Eden Prairie, MN 55346 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-22 |
| Decision Date | 1999-06-02 |
| Summary: | summary |