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510(k) K902116

MODIFIED ENDOBRONCHIAL TUBE by Concord/Portex — Product Code BTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1990
Date Received
May 10, 1990
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 Concord/Portex

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  • K930218 — SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (July 27, 1993)
  • K924541 — EPIDURAL MINIPACK (July 9, 1993)
  • K930286 — DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS (June 22, 1993)
  • K923127 — NEEDLE-PRO CARTRIDGE (April 29, 1993)
  • K923910 — HEAT MOISTURE CONDENSER (January 26, 1993)
  • K922749 — LOW PROFILE TRACHEOSTOMY TUBE (September 2, 1992)
  • K922445 — VACU-PRO (August 12, 1992)
  • K915452 — ANESTHESIA BREATHING CIRCUIT (February 14, 1992)
  • K911809 — NEW-VENT (August 26, 1991)

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)
  • K834565 — ENDOBRONCHIAL TWIN LUMEN TUBE (January 17, 1984)
  • K833297 — BRONCHOSCOPY TUBE W/ULTRA LOCUFF (December 27, 1983)
  • K771219 — BRONCHO-CATH (August 4, 1977)