← Product Code [BTO](/productcode/BTO) · K253063

# Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063)

_Vitaltec Corporation · BTO · Sep 11, 2026 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253063

## Device Facts

- **Applicant:** Vitaltec Corporation
- **Product Code:** [BTO](/productcode/BTO.md)
- **Decision Date:** Sep 11, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **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/device/K253063](https://fda.innolitics.com/device/K253063)

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