TRACHEAL TUBE FIXATION DEVICE— 510(k) K843790

Name: FDA 510(k) clearance K843790
Creator: U.S. Food and Drug Administration
Published: 1985-03-11

Substantially Equivalent

Laerdal California, Inc.

FDA 510(k) clearance K843790 for TRACHEAL TUBE FIXATION DEVICE, Substantially Equivalent on 1985-03-11. Applicant: Laerdal California, Inc.. Device class: 1.

Clearance details

Applicant: Laerdal California, Inc.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1984-09-27
Decision date: 1985-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBH

view all

K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM2014-09-24
K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/2801997-01-28
K942529 — HCI TUBE STABILIZER1995-06-14
K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS1995-04-24
K950930 — TRACHE-TITE1995-03-22

More clearances from Laerdal California, Inc.

view all

K941578 — STATVAC PORTABLE SUCTION UNIT1994-05-18
K922842 — STYLET AND TRACHEAL LIGHTWAND (STL)1992-12-18
K862875 — E-VAC(TM)1986-11-03
K832990 — STIFNICK IMMOBILIZING COLLAR1983-11-07

Adverse events under product code CBH

product code CBH

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.