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510(k) K110631

VENNER TRACHEAL SEAL MONITOR by Venner Medical (Singapore) Pte, Ltd. — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2011
Date Received
March 4, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

Other clearances by Venner Medical (Singapore) Pte, Ltd.

  • K192511 — Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy (July 22, 2020)
  • K192120 — Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tu (February 14, 2020)
  • K191602 — APA Oxy Blade (August 2, 2019)
  • K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (July 13, 2010)
  • K093135 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE (April 2, 2010)

Other clearances for product code BSK

  • K243562 — CuffGuard (August 12, 2025)
  • K242642 — CuffTrek (March 7, 2025)
  • K220854 — TrachCuff Cuff Controller (April 14, 2023)
  • K221477 — AG100s (December 29, 2022)
  • K202874 — Puritan Bennett Cuff Pressure Manager (January 9, 2021)
  • K192611 — Cuffix (August 13, 2020)
  • K191858 — Pylant Monitor (February 24, 2020)
  • K182548 — Accucuff Cuff Pressure Indicator (January 25, 2019)
  • K180991 — AG 100s (October 12, 2018)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)