← Product Code [BTO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO) · K801931

# MARTIN TRACH-SECURE (K801931)

_Acucare Medical, Inc. · BTO · Aug 27, 1980 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K801931

## Device Facts

- **Applicant:** Acucare Medical, Inc.
- **Product Code:** [BTO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO.md)
- **Decision Date:** Aug 27, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5800
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K801931](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K801931)

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