← Product Code [JOH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH) · K925438

# COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT (K925438)

_Aga Medical Products, Inc. · JOH · Feb 17, 1993 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH/K925438

## Device Facts

- **Applicant:** Aga Medical Products, Inc.
- **Product Code:** [JOH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH.md)
- **Decision Date:** Feb 17, 1993
- **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/JOH/K925438](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH/K925438)

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