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510(k) K834565

ENDOBRONCHIAL TWIN LUMEN TUBE by Portex, Inc. — Product Code BTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1984
Date Received
December 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Bronchial (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5720
Review Panel
AN
Submission Type

Other clearances by Portex, Inc.

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  • K040014 — PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTROD (February 13, 2004)
  • K032112 — P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) (January 26, 2004)
  • K033084 — WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER (December 19, 2003)
  • K032716 — PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERI (November 28, 2003)
  • K030570 — BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE (September 17, 2003)
  • K030381 — PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA (August 27, 2003)
  • K031057 — PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT (July 18, 2003)
  • K031622 — WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS (June 26, 2003)
  • K023793 — 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR (February 11, 2003)

Other clearances for product code BTS

  • K953963 — RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIA (November 27, 1995)
  • K951091 — RUSCH ENDOBRONCHIAL TUBE SETS (June 8, 1995)
  • K902116 — MODIFIED ENDOBRONCHIAL TUBE (August 3, 1990)
  • K833297 — BRONCHOSCOPY TUBE W/ULTRA LOCUFF (December 27, 1983)
  • K771219 — BRONCHO-CATH (August 4, 1977)