The following data is part of a premarket notification filed by Sulzer Intratherapeutics, Inc. with the FDA for Intracoil Self-expanding Peripheral Stent.
| Device ID | K021563 |
| 510k Number | K021563 |
| Device Name: | INTRACOIL SELF-EXPANDING PERIPHERAL STENT |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | SULZER INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 -3495 |
| Contact | Maria E Brittle |
| Correspondent | Maria E Brittle SULZER INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 -3495 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-13 |
| Decision Date | 2002-05-31 |
| Summary: | summary |