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510(k) K981080

SCOOP 1 by Transtracheal Systems — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1998
Date Received
March 24, 1998
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)
  • K962944 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) (October 23, 1996)
  • K904748 — TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 (March 1, 1991)
  • K904749 — TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 (March 1, 1991)
  • K902281 — MODIFIED SCOOP TRANSTRACHEAL CATHETERS (August 10, 1990)
  • K854252 — TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER (February 3, 1986)

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  • 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)