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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, tracheal, expandable, polymeric
Regulation Description Tracheal prosthesis.
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.
Physical State The device is a self-expanding tubular device, traditionally made of silicone. Devices can range roughly from 6-14mm in diameter and have lengths as small as 20 mm to lengths as long as 150mm.
Technical Method The device functions independently providing physical support to the constricting airway.
Target Area The target area is the tracheobronchial tree.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNYT
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.3720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible