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JCT — Prosthesis, Tracheal, Expandable Class II

FDA Device Classification

Classification Details

Product Code
JCT
Device Class
Class II
Regulation Number
878.3720
Submission Type
Review Panel
AN
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230269boston scientific corporationUltraflex™ Tracheobronchial Stent SystemJuly 14, 2023
K220424micro-tech (nanjing) coThrough the Scope Tracheal Stent SystemJuly 8, 2022
K212403micro-tech (nanjing) coTracheal Stent System (Y-Shaped)October 30, 2021
K202204micro-tech (nanjing) coTracheal Stent SystemSeptember 1, 2021
K201342m.i. tech coHANAROSTENT Trachea/Bronchium (CCC)December 31, 2020
K181200merit medical systemsAEROmini Tracheobronchial Stent SystemSeptember 21, 2018
K152842boston scientific corporationWALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBMay 19, 2016
K140382merit medical systemsAEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGYNovember 25, 2014
K140472endochoiceBONASTENT TRACHEAL / BRONCHIALOctober 17, 2014
K141584boston scientific corporationULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEMOctober 16, 2014
K121048boston scientificULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVEREDAugust 3, 2012
K083625alveolusAERO DV TRACHEOBRONCHIAL STENT SYSTEMMarch 11, 2009
K082284alveolusAERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEMNovember 20, 2008
K071604alveolusALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEMSeptember 19, 2007
K062511alveolusAERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XXJanuary 31, 2007
K050832bard peripheral vascularFLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTJuly 7, 2005
K050814atrium medicalATRIUM ICAST COVERED STENTMay 6, 2005
K041269atrium medicalATRIUM MEDICAL CORPORATION ICAST COVERED STENTSeptember 14, 2004
K033990alveolusALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEMMay 12, 2004
K033053alveolusALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEMFebruary 25, 2004