AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX— 510(k) K062511

Unknown

Alveolus, Inc.

FDA 510(k) clearance K062511 for AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX, Unknown on 2007-01-31. Applicant: Alveolus, Inc..

Clearance details

Applicant: Alveolus, Inc.
Product code: Code JCT
Advisory panel: General, Plastic Surgery
Date received: 2006-08-28
Decision date: 2007-01-31
Decision: Unknown
Clearance type: Traditional
Location: Charlotte, NC, US

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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.