Last synced on 2 May 2025 at 11:05 pm

Tracheal Prosthesis With Cover Material Derived From Human Sources

Page Type
Product Code
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.
Physical State
The device is a self-expanding tubular device, traditionally made of metal material, and covered with a human-sourced decellularized material. This device may also include a device delivery system.
Technical Method
The device functions independently, providing opening physical forces to the constricting airway and resisting migration.
Target Area
Tracheobronchial tree and trachea
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.3721
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code SDB is linked to regulation 21CFR868.3721, which does not seem to exist yet. It may be pending at the moment.

Tracheal Prosthesis With Cover Material Derived From Human Sources

Page Type
Product Code
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.
Physical State
The device is a self-expanding tubular device, traditionally made of metal material, and covered with a human-sourced decellularized material. This device may also include a device delivery system.
Technical Method
The device functions independently, providing opening physical forces to the constricting airway and resisting migration.
Target Area
Tracheobronchial tree and trachea
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.3721
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code SDB is linked to regulation 21CFR868.3721, which does not seem to exist yet. It may be pending at the moment.