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510(k) K854252

TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER by Transtracheal Systems — Product Code BTO

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
February 3, 1986
Date Received
October 22, 1985
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 Transtracheal Systems

  • K982943 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 (July 12, 1999)
  • K981078 — TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 (July 23, 1998)
  • K981080 — SCOOP 1 (June 17, 1998)
  • K962944 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) (October 23, 1996)
  • K904749 — TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 (March 1, 1991)
  • K904748 — TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 (March 1, 1991)
  • K902281 — MODIFIED SCOOP TRANSTRACHEAL CATHETERS (August 10, 1990)

Other clearances for product code BTO

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  • 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)