← Product Code [CAO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO) · K894032

# EVAC-TUBE (K894032)

_Sharn, Inc. · CAO · Aug 31, 1989 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K894032

## Device Facts

- **Applicant:** Sharn, Inc.
- **Product Code:** [CAO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO.md)
- **Decision Date:** Aug 31, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5650
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K894032](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K894032)

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