Product Code: CBI FDA class 2 21 CFR 868.5740

Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Anesthesiology

The Tracheal/Bronchial Differential Ventilation Tube is an anesthesiology device designed for selective or differential ventilation of the lungs, featuring a double-lumen or specialized design that allows independent ventilation of the left and right lungs, used in thoracic surgery and other procedures requiring lung separation. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBI, regulated under 21 CFR 868.5740, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CBI
Device Class: FDA class 2
Regulation Number: 868.5740
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251950	Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)	Mar 20, 2026	Substantially Equivalent	Hangzhou Tappa Medical Technology Co., Ltd.
K253096	Chartis Precision Catheter	Feb 13, 2026	Substantially Equivalent	Pulmonx Corporation
K232529	Disposable Double Lumen Endobronchial Tube	May 13, 2024	Substantially Equivalent	Shenzhen Insighters Medical Technology Co., Ltd.
K232580	Disposable Endobronchial Blocker Tube	Dec 14, 2023	Substantially Equivalent	Shenzhen Insighters Medical Technology Co., Ltd.
K222340	Chartis Precision Catheter	Dec 01, 2022	Substantially Equivalent	Pulmonx Corporation
K201026	sOLVe Tube	Aug 10, 2021	Substantially Equivalent	Hytek Medical, Inc.
K203749	Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable	May 03, 2021	Substantially Equivalent	Ambu A/S
K200968	ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R	Dec 28, 2020	Substantially Equivalent	Insung Medical Co., Ltd.
K181886	VivaSight-DL System	Nov 14, 2018	Substantially Equivalent	Etview , Ltd.
K180253	Sheridan Endobronchial Tubes	Nov 02, 2018	Substantially Equivalent	Teleflex Medical
K160542	5.0 Fr Arndt Endobronchial Blocker Set	Aug 02, 2016	Substantially Equivalent	Cook Incorporated
K152251	Endobronchial Tube	Jun 10, 2016	Substantially Equivalent	Henan Tuoren Medical Device Co., Ltd.
K141888	RUSCH ENDOBRONCHIAL TUBES	Apr 15, 2015	Substantially Equivalent	Teleflexmedical, Inc.
K123853	VIVASIGHT-DL SYSTEM	Apr 15, 2013	Substantially Equivalent	Etview , Ltd.
K121462	EZ-BLOCKER	Sep 28, 2012	Substantially Equivalent	Ez-Blocker B.V.
K120334	VIVA EB	Jun 08, 2012	Substantially Equivalent	Etview , Ltd.
K113576	DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM	May 18, 2012	Substantially Equivalent	Etview , Ltd.
K111522	CHARTIS CATHETER MODEL CHR-CA-12.0	Sep 29, 2011	Substantially Equivalent	Pulmonx, Inc.
K093888	COOPDECH ENDOBRONCHIAL BLOCKER TUBE	Mar 16, 2010	Substantially Equivalent	Daiken Medical Co, Ltd.
K092886	WELL LEAD ENDOBRONCHIAL TUBES	Mar 11, 2010	Substantially Equivalent	Well Lead Instruments
K083883	CHARTIS CATHETER	Jun 25, 2009	Substantially Equivalent	Pulmonx, Inc.
K071694	COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX	Mar 20, 2008	Substantially Equivalent	Daiken Medical Co, Ltd.
K051522	SILBRONCHO DOUBLE LUMEN TUBE	Aug 17, 2005	Substantially Equivalent	Fuji Systems Corp.
K021920	7.0 FR. ENDOBRONCHIAL BLOCKER	Aug 14, 2002	Substantially Equivalent	Cook, Inc.
K013865	TIP DEFLRCTING ENDOBRONCHIAL BLOCKER	Apr 22, 2002	Substantially Equivalent	Cook, Inc.
K010596	RUSCH BRONCHUS BLOCKER KIT	Nov 21, 2001	Substantially Equivalent	Rusch Intl.
K002288	ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER	Nov 28, 2000	Substantially Equivalent	Cook, Inc.
K962167	BRONCHIAL BLOCKER	Aug 29, 1997	Substantially Equivalent	Cook, Inc.
K961977	KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE	Jul 31, 1996	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K953483	SIMS BLUE LINE ENDOBRONCHIAL TUBE	Oct 24, 1995	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K925615	SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE	Mar 26, 1993	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K897046	LASER RESISTANT TRACHEAL TUBE	Mar 23, 1990	Substantially Equivalent	Sheridan Catheter Corp.
K894337	UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM	Sep 29, 1989	Substantially Equivalent	Vitaid, Ltd.
K851856	TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE	May 23, 1985	Substantially Equivalent	Sheridan Catheter Corp.