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510(k) K232580

Disposable Endobronchial Blocker Tube by Shenzhen Insighters Medical Technology Co., Ltd. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2023
Date Received
August 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type

Other clearances by Shenzhen Insighters Medical Technology Co., Ltd.

  • K242793 — Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; In (May 28, 2025)
  • K232529 — Disposable Double Lumen Endobronchial Tube (May 13, 2024)

Other clearances for product code CBI

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  • K222340 — Chartis Precision Catheter (December 1, 2022)
  • K201026 — sOLVe Tube (August 10, 2021)
  • K203749 — Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (May 3, 2021)
  • K200968 — ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (December 28, 2020)
  • K181886 — VivaSight-DL System (November 14, 2018)
  • K180253 — Sheridan Endobronchial Tubes (November 2, 2018)
  • K160542 — 5.0 Fr Arndt Endobronchial Blocker Set (August 2, 2016)
  • K152251 — Endobronchial Tube (June 10, 2016)