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510(k) K862909

RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM by Intl. Medical Devices , Ltd. — Product Code BTO

K862909 is an FDA 510(k) premarket notification submitted by Intl. Medical Devices , Ltd. for the device "RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Intl. Medical Devices , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
July 31, 1986
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 Intl. Medical Devices , Ltd.

  • K913541 — NEO-THOR THORACOSTOMY KIT (April 9, 1992)
  • K913540 — PEDIA-THOR THORACOSTOMY KIT (April 9, 1992)
  • K913542 — THORACIC CATHETER WITH GUIDE (January 21, 1992)
  • K913539 — THORACIC CATHTER STYLET (January 21, 1992)
  • K913543 — THORACIC CATHETER STYLET (October 4, 1991)
  • K850398 — NU-CATH EMERGENCY KIT (March 27, 1985)
  • K843785 — WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR (October 23, 1984)
  • K842666 — NU-THOR THORACOSTOMY KIT (September 20, 1984)
  • K840925 — PEDIA-TRAKE CRICOTHYROTOMY KIT (May 2, 1984)
  • K820778 — RESPIRATION MONITOR 1000 (May 3, 1982)

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)

FDA data resources