Tracheal Stent System— 510(k) K202204

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K202204 for Tracheal Stent System, Substantially Equivalent on 2021-09-01. Applicant: Micro-Tech (Nanjing) Co., Ltd..

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code JCT
Advisory panel: General, Plastic Surgery
Date received: 2020-08-05
Decision date: 2021-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

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.