Ultraflex Tracheobronchial Stent System— 510(k) K230269

Name: FDA 510(k) clearance K230269
Creator: U.S. Food and Drug Administration
Published: 2023-07-14

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K230269 for Ultraflex Tracheobronchial Stent System, Substantially Equivalent on 2023-07-14. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code JCT
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Date received: 2023-01-31
Decision date: 2023-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCT

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K220424 — Through the Scope Tracheal Stent System2022-07-08
K212403 — Tracheal Stent System (Y-Shaped)2021-10-30
K202204 — Tracheal Stent System2021-09-01
K201342 — HANAROSTENT Trachea/Bronchium (CCC)2020-12-31
K181200 — AEROmini Tracheobronchial Stent System2018-09-21

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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.