Tracheal Prosthesis With Cover Material Derived From Human Sources
- US Product Code (FDA)
- SDBView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 868.3721View CFR Regulation →
- Medical specialty
- Anesthesiology
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
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.
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Tracheal Prosthesis With Cover Material Derived From Human Sources is a medical device type in the Anesthesiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.