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
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HANAROSTENT Trachea/Bronchium (CCC)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201342
- 510(k) Type
- Traditional
- Applicant
- M.I. Tech Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/31/2020
- Days to Decision
- 225 days
- Submission Type
- Summary