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510(k) K953483

SIMS BLUE LINE ENDOBRONCHIAL TUBE by Smiths Industries Medical Systems, Inc. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1995
Date Received
July 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type

Other clearances by Smiths Industries Medical Systems, Inc.

  • K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED (January 20, 1998)
  • K965017 — REGIONAL ANESTHESIA TRAYS (March 14, 1997)
  • K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE (January 17, 1997)
  • K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT (October 21, 1996)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. IN (May 2, 1996)
  • K953485 — SIMS CPAP SYSTEM (October 26, 1995)
  • K932947 — WALLACE Y-CAN (September 1, 1995)
  • K932946 — WALLACE IV CANNULA (September 1, 1995)
  • K952516 — PRO-VENT, LINE DRAW, PULSATOR (July 14, 1995)

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  • K232529 — Disposable Double Lumen Endobronchial Tube (May 13, 2024)
  • K232580 — Disposable Endobronchial Blocker Tube (December 14, 2023)
  • K222340 — Chartis Precision Catheter (December 1, 2022)
  • K201026 — sOLVe Tube (August 10, 2021)
  • K203749 — Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (May 3, 2021)
  • K200968 — ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (December 28, 2020)
  • K181886 — VivaSight-DL System (November 14, 2018)
  • K180253 — Sheridan Endobronchial Tubes (November 2, 2018)
  • K160542 — 5.0 Fr Arndt Endobronchial Blocker Set (August 2, 2016)