Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5720](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5720) → BTS — Tube, Bronchial (W/Wo Connector)

# BTS · Tube, Bronchial (W/Wo Connector)

_Anesthesiology · 21 CFR 868.5720 · Class 2_

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

## Overview

- **Product Code:** BTS
- **Device Name:** Tube, Bronchial (W/Wo Connector)
- **Regulation:** [21 CFR 868.5720](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5720)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **Life-sustaining:** yes

## Identification

A bronchial tube is a device used to differentially intubate a patient's bronchus (one of the two main branches of the trachea leading directly to the lung) in order to isolate a portion of lung distal to the tube.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K953963](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTS/K953963.md) | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION | Rusch, Inc. | Nov 27, 1995 | SESE |
| [K951091](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTS/K951091.md) | RUSCH ENDOBRONCHIAL TUBE SETS | Rusch Intl. | Jun 8, 1995 | SESE |
| [K902116](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTS/K902116.md) | MODIFIED ENDOBRONCHIAL TUBE | Concord/Portex | Aug 3, 1990 | SESE |
| [K834565](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTS/K834565.md) | ENDOBRONCHIAL TWIN LUMEN TUBE | Portex, Inc. | Jan 17, 1984 | SESE |
| [K833297](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTS/K833297.md) | BRONCHOSCOPY TUBE W/ULTRA LOCUFF | Surgitek | Dec 27, 1983 | SESE |
| [K771219](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTS/K771219.md) | BRONCHO-CATH | Mallinckrodt Critical Care | Aug 4, 1977 | SESE |

## Top Applicants

- Concord/Portex — 1 clearance
- Mallinckrodt Critical Care — 1 clearance
- Portex, Inc. — 1 clearance
- Rusch Intl. — 1 clearance
- Rusch, Inc. — 1 clearance

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

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