WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING— 510(k) K980163

Substantially Equivalent

Boston Scientific Scimed, Inc.

FDA 510(k) clearance K980163 for WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING, Substantially Equivalent on 1998-03-13. Applicant: Boston Scientific Scimed, Inc..

Clearance details

Applicant: Boston Scientific Scimed, Inc.
Product code: Code JCT
Advisory panel: General, Plastic Surgery
Date received: 1998-01-16
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.