CAO · Airway, Esophageal (Obturator)
Anesthesiology · 21 CFR 868.5650 · Class 2
Overview
| Product Code | CAO |
|---|---|
| Device Name | Airway, Esophageal (Obturator) |
| Regulation | 21 CFR 868.5650 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
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.
Classification Rationale
Class II (performance standards).
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971348 | FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM | Green Field Medical Sourcing, Inc. | Feb 27, 1998 | SESE |
| K894032 | EVAC-TUBE | Sharn, Inc. | Aug 31, 1989 | SESE |
| K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Sheridan Catheter Corp. | Jan 19, 1988 | SESE |
| K864200 | VETA/VENTED ESOPHAGEAL TUBE AIRWAY | Cranco Co. | Mar 17, 1987 | SESE |
| K863172 | RESPIRONICS PTL REVIVEEASY | Respironics, Inc. | Nov 4, 1986 | SESE |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | Mckesson Corp. | Dec 9, 1976 | SESE |
Top Applicants
- Sheridan Catheter Corp. — 1 clearance
- Sharn, Inc. — 1 clearance
- Respironics, Inc. — 1 clearance
- Mckesson Corp. — 1 clearance
- Green Field Medical Sourcing, Inc. — 1 clearance
