Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological 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)
- K121048ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED2Cleared 510(K)
- K083625AERO DV TRACHEOBRONCHIAL STENT SYSTEM2Cleared 510(K)
- K082284AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM2Cleared 510(K)
- K071604ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM2Cleared 510(K)
- K062511AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX2Cleared 510(K)
- K050832FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT2Cleared 510(K)
- K050814ATRIUM ICAST COVERED STENT2Cleared 510(K)
- K041269ATRIUM MEDICAL CORPORATION ICAST COVERED STENT2Cleared 510(K)
- K033990ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM2Cleared 510(K)
- K033053ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM2Cleared 510(K)
- K032744ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM2Cleared 510(K)
- K031641VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM2Cleared 510(K)
- K031041FLUENCY TRACHEOBRONCHIAL STENT GRAFT2Cleared 510(K)
- K030947ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM2Cleared 510(K)
- K030567MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM2Cleared 510(K)
- K024178VIATORR ENDOPROSTHESIS2Cleared 510(K)
- K023811MODIFICATION TO VIABAHN ENDOPROSTHESIS2Cleared 510(K)
- K021901WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM2Cleared 510(K)
- K021563INTRACOIL SELF-EXPANDING PERIPHERAL STENT2Cleared 510(K)
- K013648VIABAHN ENDOPROSTHESIS2Cleared 510(K)
- K012544VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM2Cleared 510(K)
- K003100WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM2Cleared 510(K)
- K000001WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM2Cleared 510(K)
- K001257INTRACOIL STENT2Cleared 510(K)
- K992510WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM2Cleared 510(K)
- K990221INTRACOIL PERIPHERAL STENT2Cleared 510(K)
- K982184WALLSTENT ENDOPROSTHESIS2Cleared 510(K)
- K980163WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING2Cleared 510(K)
- K964121WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS2Cleared 510(K)
- K963241ULTRAFLEX2Cleared 510(K)
- K961507WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS2Cleared 510(K)
- K961296WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS2Cleared 510(K)
- K945494WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS2Cleared 510(K)
- K934116WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION2Cleared 510(K)
- K891411GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT2Cleared 510(K)
- 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
ULTRAFLEX
- Page Type
- Cleared 510(K)
- 510(k) Number
- K963241
- 510(k) Type
- Traditional
- Applicant
- BOSTON SCIENTIFIC CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent - Subject to Tracking Regulation
- Decision Date
- 11/14/1996
- Days to Decision
- 87 days