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510(k) K896798

TRACHEOSTOMY TRAY by Westmark, Sterile Packing Systems, Inc. (Sps) — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1990
Date Received
December 1, 1989
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 Westmark, Sterile Packing Systems, Inc. (Sps)

  • K896800 — IRRIGATION TRAY (May 24, 1990)
  • K896799 — PARACERVICAL/PUDENDAL TRAYS (April 23, 1990)
  • K896559 — INFANT FEEDING TUBE (March 13, 1990)
  • K896794 — SPECIMEN CONTAINER (March 1, 1990)
  • K896806 — CATHETER PLUG/PROTECTOR (February 26, 1990)
  • K896797 — SUCTION CATHETER KIT (February 16, 1990)
  • K896215 — MERCY HIP/KNEE PACK (February 13, 1990)
  • K896804 — MANIFOLD (February 8, 1990)
  • K896557 — YANKAUER SUCTION TUBE-FLEXIBLE TYPE (February 6, 1990)
  • K896558 — YANKAUER SUCTION TUBE-RIGID TYPE (February 6, 1990)

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)
  • K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (July 13, 2010)
  • 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)