Anesthesiology
Review Panel
- Cardiovascular Diagnostic DevicesCFR Sub-Part
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Therapeutic DevicesCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousCFR Sub-Part
- Monitoring DevicesCFR Sub-Part
- Neurological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- JCTProsthesis, Tracheal, Expandable2Product Code
- K212403Tracheal Stent System (Y-Shaped)2Cleared 510(K)
- K202204Tracheal Stent System2Cleared 510(K)
- K201342HANAROSTENT Trachea/Bronchium (CCC)2Cleared 510(K)
- K181200AEROmini Tracheobronchial Stent System2Cleared 510(K)
- K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL2Cleared 510(K)
- K140382AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY2Cleared 510(K)
- K140472BONASTENT TRACHEAL / BRONCHIAL2Cleared 510(K)
- K141584ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM2Cleared 510(K)
- K121048ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED2Cleared 510(K)
- K083625AERO DV TRACHEOBRONCHIAL STENT SYSTEM2Cleared 510(K)
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Tracheal Stent System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K202204
- 510(k) Type
- Traditional
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/1/2021
- Days to Decision
- 392 days
- Submission Type
- Summary