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510(k) K123853

VIVASIGHT-DL SYSTEM by Etview , Ltd. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2013
Date Received
December 14, 2012
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 Etview , Ltd.

  • K181880 — VivaSight-SL (TVT) system (November 29, 2018)
  • K181886 — VivaSight-DL System (November 14, 2018)
  • K152438 — ETView VivaSight-SL (TVT) system (February 25, 2016)
  • K121028 — ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) (June 21, 2012)
  • K120334 — VIVA EB (June 8, 2012)
  • K113576 — DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM (May 18, 2012)
  • K082420 — TRACHEOSCOPIC VENTILATION TUBE (TVT) (October 8, 2008)
  • K052233 — TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM (December 13, 2005)

Other clearances for product code CBI

  • K253096 — Chartis Precision Catheter (February 13, 2026)
  • K232529 — Disposable Double Lumen Endobronchial Tube (May 13, 2024)
  • K232580 — Disposable Endobronchial Blocker Tube (December 14, 2023)
  • 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)