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SDBClass II

Tracheal Prosthesis With Cover Material Derived From Human Sources

21 CFR 868.3721 / Anesthesiology
FDA source (opens on fda.gov)

SDB is the FDA product code for Tracheal Prosthesis With Cover Material Derived From Human Sources, a class II device type, regulated under 21 CFR 868.3721. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SDB
Device name
Tracheal Prosthesis With Cover Material Derived From Human Sources
FDA 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.
Regulation
21 CFR 868.3721
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SDB

By decision year
1 clearance under product code SDB with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SDB by decision year
YearClearances
20241

Applicants with the most clearances

Product code SDB
Applicants holding the most 510(k) clearances under product code SDB
ApplicantClearances
Peytant Solutions1

Companies listing this code with FDA

Companies whose registered establishments list this code