Prosthesis, Tracheal, Expandable, Polymeric

NYT · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3720

Classification

FDA Product Code: NYT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.3720
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown