SDB · Class II · 21 CFR 868.3721

FDA Product Code SDB: Tracheal Prosthesis With Cover Material Derived From Human Sources

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.

Leading manufacturers include Peytant Solutions, Inc..

1
Total
0
Cleared
301d
Avg days
2024
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Tracheal Prosthesis With Cover Material Derived From Human Sources Devices (Product Code SDB)

1 devices
1–1 of 1
Not Cleared Oct 16, 2024
AMStent® Tracheobronchial Covered Stent System
DEN230087
Peytant Solutions, Inc.
Anesthesiology · 301d

About Product Code SDB - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SDB since 2024, with 0 receiving FDA clearance (average review time: 301 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SDB devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →