ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM— 510(k) K033053

Substantially Equivalent

Alveolus, Inc.

FDA 510(k) clearance K033053 for ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM, Substantially Equivalent on 2004-02-25. Applicant: Alveolus, Inc..

Clearance details

Applicant: Alveolus, Inc.
Product code: Code JCT
Advisory panel: General, Plastic Surgery
Date received: 2003-09-29
Decision date: 2004-02-25
Decision: Substantially Equivalent
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.