510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083625Unknown

Aero Dv Tracheobronchial Stent System

Alveolus, Inc., Charlotte NC / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083625 is the FDA 510(k) clearance record for AERO DV TRACHEOBRONCHIAL STENT SYSTEM, a class II device, cleared for Alveolus, Inc. on under FDA product code JCT (Prosthesis, Tracheal, Expandable). FDA records list 12 510(k) clearances for Alveolus, Inc., from to . As of , FDA records show no recalls naming K083625.

Clearance record

Decision date
Received
(93 days to decision)
Product code
JCT Prosthesis, Tracheal, Expandable
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Alveolus, Inc. 9013 Perimeter Woods Dr., Charlotte NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JCT

Trailing 12 months

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

FDA records show no clearances under product code JCT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JCT, 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