FDA.reportPublic FDA data

510(k) K232529

Device
Disposable Double Lumen Endobronchial Tube
Applicant
Shenzhen Insighters Medical Technology Co., Ltd.
510(k) number
K232529
Product code
CBI
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-13
Date received
2023-08-21
Regulation
868.5740
Classification name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Bonnie Fang
Address
The 13th Floor Of Hengtemei Bldg., Ganli Rd. #3 Shenzhen CN 518000 518000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CBI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251950Endobronchial 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)Hangzhou Tappa Medical Technology Co., Ltd.2026-03-20
K253096Chartis Precision CatheterPulmonx Corporation2026-02-13
K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd.2023-12-14
K222340Chartis Precision CatheterPulmonx Corporation2022-12-01
K201026sOLVe TubeHytek Medical, Inc.2021-08-10
K203749Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S2021-05-03
K200968ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd.2020-12-28
K181886VivaSight-DL SystemEtview , Ltd.2018-11-14
K180253Sheridan Endobronchial TubesTeleflex Medical2018-11-02
K1605425.0 Fr Arndt Endobronchial Blocker SetCook Incorporated2016-08-02
K152251Endobronchial TubeHenan Tuoren Medical Device Co., Ltd.2016-06-10
K141888RUSCH ENDOBRONCHIAL TUBESTeleflexmedical, Inc.2015-04-15
K123853VIVASIGHT-DL SYSTEMEtview , Ltd.2013-04-15
K121462EZ-BLOCKEREz-Blocker B.V.2012-09-28
K120334VIVA EBEtview , Ltd.2012-06-08