AERO DV TRACHEOBRONCHIAL STENT SYSTEM— 510(k) K083625

Name: FDA 510(k) clearance K083625
Creator: U.S. Food and Drug Administration
Published: 2009-03-11

Unknown

Alveolus, Inc.

FDA 510(k) clearance K083625 for AERO DV TRACHEOBRONCHIAL STENT SYSTEM, Unknown on 2009-03-11. Applicant: Alveolus, Inc.. Device class: 2.

Clearance details

Applicant: Alveolus, Inc.
Product code: Code JCT
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Date received: 2008-12-08
Decision date: 2009-03-11
Decision: Unknown
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

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K082284 — AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM2008-11-20
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K072720 — ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM2008-04-11
K071604 — ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM2007-09-19
K062511 — AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX2007-01-31

Adverse events under product code JCT

product code JCT

Death: 20
Injury: 211
Other: 1
Total: 232

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.