Prosthesis, Tracheal, Expandable, Polymeric
The Prosthesis, Tracheal, Expandable, Polymeric (product code NYT) is an implantable polymeric tracheal stent designed to provide support to weakened or constricting airway walls, indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms or benign conditions after all alternative therapies have been exhausted. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 878.3720 within the General and Plastic Surgery specialty. This device carries an implant flag.
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Basic Information
- Product Code
- NYT
- Device Class
- FDA class 2
- Regulation Number
- 878.3720
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K013266 | RUSCH POLYFLEX STENT KIT | Nov 27, 2001 | Substantially Equivalent | Rusch Intl. |
| K982614 | RUSCH POLYFLEX STENT KIT | Dec 04, 1998 | Substantially Equivalent | Rusch Intl. |
| K953593 | RUSCH TRACHEAL BRONCHIAL Y STENT | Oct 13, 1995 | Substantially Equivalent - Subject to Tracking Reg. | Rusch, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.