510(k) K982614
K982614 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH POLYFLEX STENT KIT". The FDA issued a decision of Substantially Equivalent on December 4, 1998. The device falls under product code NYT (Prosthesis, Tracheal, Expandable, Polymeric), a Class II device regulated under 21 CFR 878.3720. Rusch Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1998
- Date Received
- July 27, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Tracheal, Expandable, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- SU
- Submission Type
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.