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510(k) K853051

TRACHEAL TUBES by Erie Medical — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1986
Date Received
July 19, 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 Erie Medical

  • K861865 — ERIE-NEB (July 1, 1986)
  • K853039 — PRESSURE REGULATOR (April 11, 1986)
  • K853040 — PRESSURE GAUGE (October 10, 1985)
  • K832466 — TRACHEAL TUBE 16 GAUGE-1.65MM- (September 19, 1984)

Other clearances for product code BTO

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  • 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)