510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230087Unknown

AMStent® Tracheobronchial Covered Stent System

Peytant Solutions, Plymouth MN / Direct, Unknown
FDA source (opens on fda.gov)

DEN230087 is the FDA 510(k) clearance record for AMStent® Tracheobronchial Covered Stent System, a class II device, cleared for Peytant Solutions, Inc. on under FDA product code SDB (Tracheal Prosthesis With Cover Material Derived From Human Sources). FDA's definition for product code SDB 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...". FDA records list one 510(k) clearance for Peytant Solutions, Inc. As of , FDA records show no recalls naming DEN230087.

Clearance record

Decision date
Received
(301 days to decision)
Product code
SDB Tracheal Prosthesis With Cover Material Derived From Human Sources
Regulation
21 CFR 868.3721
Device class
Class II
Review panel
Anesthesiology
Applicant
Peytant Solutions, Inc. 3650 Annapolis Ln. N., #180, Plymouth MN
Third party review
No

Clearances, product code SDB

Trailing 12 months

FDA records hold no clearances under product code SDB in the trailing twelve months.

FDA records show no clearances under product code SDB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SDB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260