Heimlich Micro Trach

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

510(k) Number

K895130 ↗

FDA Product Code

BTO

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Safety Shield Suction Catheter

  Class I

  FDA 510(k) K873810 Active Cleared 11 Dec 1987

• Safety Shield Kit

  Class II

  FDA 510(k) K873731 Active Cleared 15 Jan 1988

• Reusable Bronchial Biopsy Forceps

  Class II

  FDA 510(k) K022398 Active Cleared 11 Oct 2002

• Trach Care Start Kit

  Class I

  FDA 510(k) K873732 Active Cleared 13 Oct 1987

• Trach Care Catheter

  Class I

  FDA 510(k) K872621 Active Cleared 15 Sep 1987

• 72 Hour Use Trach Care with Microban

  Class II

  FDA 510(k) K974630 Active Cleared 11 Mar 1998

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• What is the Heimlich Micro Trach used for?

  The Heimlich Micro Trach is designed for temporary or permanent airway management in patients requiring tracheal access. It ensures secure airway patency in critical settings like intensive care units or operating rooms, where maintaining an open airway is essential for patient safety and respiratory support.

• How is the Heimlich Micro Trach supplied, and what models are available?

  The Heimlich Micro Trach is supplied as either a single-use or reusable device, depending on the specific model variant. It comes in multiple reference codes, such as 1721676, 3021632375, and others, indicating different configurations, including variations with or without connectors. These models cater to diverse clinical needs in anesthesia and critical care environments.

• Is sterility or MRI safety information provided for the Heimlich Micro Trach?

  The provided data does not specify whether the Heimlich Micro Trach is sterile or MRI-safe. Clinicians should verify these details with the manufacturer or product documentation before use, especially in procedures involving MRI or sterile field requirements.

• What regulatory pathway does the Heimlich Micro Trach follow?

  The Heimlich Micro Trach is regulated under the FDA 510(k) clearance pathway, specifically with the clearance number K895130. It is classified under device class 2 and falls under the product code BTO for tracheostomy tubes. This classification ensures it meets established safety and effectiveness standards for use in anesthesia and critical care.

• How should the Heimlich Micro Trach be stored?

  While specific storage conditions are not detailed in the provided data, standard medical device handling practices should be followed. This includes protecting the device from contamination, extreme temperatures, and physical damage. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain device integrity and functionality.