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Telefelx Isis Hvt Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with Stylet

by Teleflexmedical, Inc.

510(k) K141939

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141939 Date24 Nov 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTR
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Teleflex Isis HVT Tracheal Tube is a cuffed tracheal tube designed for airway management via oral intubation during mechanical ventilation and anesthesia. It incorporates a subglottic secretion suction port to facilitate the removal of subglottic secretions, reducing the risk of complications associated with retained secretions.

This single-use, sterile device is constructed from a polyvinyl chloride tube body, cuff inflation line, pilot balloon, and a compatible one-way valve. Supplied for use in clinical settings requiring tracheal intubation, it adheres to regulatory standards under classification BTR and regulation 868.5730. The device is intended for one-time use and must be discarded after use to maintain sterility and safety.

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