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CBI — Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class II

FDA Device Classification

Classification Details

Product Code
CBI
Device Class
Class II
Regulation Number
868.5740
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253096pulmonx corporationChartis Precision CatheterFebruary 13, 2026
K232529shenzhen insighters medical technology coDisposable Double Lumen Endobronchial TubeMay 13, 2024
K232580shenzhen insighters medical technology coDisposable Endobronchial Blocker TubeDecember 14, 2023
K222340pulmonx corporationChartis Precision CatheterDecember 1, 2022
K201026hytek medicalsOLVe TubeAugust 10, 2021
K203749ambuAmbu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableMay 3, 2021
K200968insung medical coABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RDecember 28, 2020
K181886etviewVivaSight-DL SystemNovember 14, 2018
K180253teleflex medicalSheridan Endobronchial TubesNovember 2, 2018
K160542cook incorporated5.0 Fr Arndt Endobronchial Blocker SetAugust 2, 2016
K152251henan tuoren medical device coEndobronchial TubeJune 10, 2016
K141888teleflexmedicalRUSCH ENDOBRONCHIAL TUBESApril 15, 2015
K123853etviewVIVASIGHT-DL SYSTEMApril 15, 2013
K121462ez-blockerEZ-BLOCKERSeptember 28, 2012
K120334etviewVIVA EBJune 8, 2012
K113576etviewDOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEMMay 18, 2012
K111522pulmonxCHARTIS CATHETER MODEL CHR-CA-12.0September 29, 2011
K093888daiken medical coCOOPDECH ENDOBRONCHIAL BLOCKER TUBEMarch 16, 2010
K092886well lead instrumentsWELL LEAD ENDOBRONCHIAL TUBESMarch 11, 2010
K083883pulmonxCHARTIS CATHETERJune 25, 2009