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510(k) K100950

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE by Venner Medical (Singapore) Pte, Ltd. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2010
Date Received
April 6, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
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)
  • K110631 — VENNER TRACHEAL SEAL MONITOR (July 28, 2011)
  • K093135 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE (April 2, 2010)

Other clearances for product code BTO

  • K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes (June 10, 2025)
  • K233713 — Pilling Tracheostomy Tubes (March 22, 2024)
  • K192511 — Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy (July 22, 2020)
  • K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestr (April 10, 2018)
  • K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (May 24, 2012)
  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (March 24, 2011)
  • K100480 — ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (June 11, 2010)
  • K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PRE (April 23, 2010)
  • K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (August 18, 2009)
  • K073702 — PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR (June 26, 2008)