Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- JCTProsthesis, Tracheal, Expandable2Product Code
- K230269Ultraflex™ Tracheobronchial Stent System2Cleared 510(K)
- K220424Through the Scope Tracheal Stent System2Cleared 510(K)
- 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)
- Show All 45 Submissions
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
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BONASTENT TRACHEAL / BRONCHIAL
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K140472
- 510(k) Type
- Traditional
- Applicant
- ENDOCHOICE, INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/17/2014
- Days to Decision
- 234 days
- Submission Type
- Summary