Tracheal Prosthesis With Cover Material Derived From Human Sources

SDB · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.3721

Classification

FDA Product Code: SDB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.3721
Review panel: AN
Medical specialty: Anesthesiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

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