Cleared Traditional

LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)

K873461 · Mallinckrodt Critical Care · Anesthesiology
Nov 1987
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K873461 is an FDA 510(k) clearance for the LASER-FLEX(TM) TRACHEAL TUBE (CUFFED), a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Mallinckrodt Critical Care (Argyle, US). The FDA issued a Cleared decision on November 6, 1987, 70 days after receiving the submission on August 28, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K873461 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 1987
Decision Date November 06, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

Similar Devices — BTR Tube, Tracheal (w/wo Connector)

All 239
Shiley? Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley? Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley? Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley? Oral RAE Tracheal Tube with TaperGuard? Cuff, Murphy Eye (115-XXOR) Shiley? Nasal RAE Tracheal Tube with TaperGuard? Cuff, Murphy Eye (119-XXNR)
K250173 · Covidien, LLC · Oct 2025
Shiley? Oral/Nasal Tracheal Tube with TaperGuard? Cuff Reinforced, Murphy Eye Shiley? Tracheal Tube TaperGuard? Cuff Reinforced with Stylet Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley? Oral/Nasal Tracheal Tube Cuffless Reinforced
K243785 · Covidien, LLC · Sep 2025
AeroJet Ventilation Catheter
K243579 · Pipeline Medical Products, LLC · Aug 2025
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
K251499 · William Cook Europe Aps · Jun 2025
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
K250243 · Flexicare Medical Limited. · May 2025
LMA Fastrach ETT SU
K242495 · Teleflex Medical · Apr 2025