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510(k) K843790

TRACHEAL TUBE FIXATION DEVICE by Laerdal California, Inc. — Product Code CBH

K843790 is an FDA 510(k) premarket notification submitted by Laerdal California, Inc. for the device "TRACHEAL TUBE FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on March 11, 1985. The device falls under product code CBH (Device, Fixation, Tracheal Tube), a Class I device regulated under 21 CFR 868.5770. Laerdal California, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1985
Date Received
September 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
Review Panel
AN
Submission Type

Other clearances by Laerdal California, Inc.

  • K941578 — STATVAC PORTABLE SUCTION UNIT (May 18, 1994)
  • K922842 — STYLET AND TRACHEAL LIGHTWAND (STL) (December 18, 1992)
  • K862875 — E-VAC(TM) (November 3, 1986)
  • K832990 — STIFNICK IMMOBILIZING COLLAR (November 7, 1983)

Other clearances for product code CBH

  • K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (September 24, 2014)
  • K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/280 (January 28, 1997)
  • K942529 — HCI TUBE STABILIZER (June 14, 1995)
  • K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (April 24, 1995)
  • K950930 — TRACHE-TITE (March 22, 1995)
  • K950318 — FLEX BLUE (February 13, 1995)
  • K942395 — ENDOTRACHEAL TUBE HOLDER (June 30, 1994)
  • K934288 — HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (June 9, 1994)
  • K942016 — TRACH TIE, VENTILATOR TUBING HOLDER (May 24, 1994)
  • K941384 — TRAKEEZ (April 19, 1994)

FDA data resources