BTS · Tube, Bronchial (W/Wo Connector)
Anesthesiology · 21 CFR 868.5720 · Class 2
Overview
| Product Code | BTS |
|---|---|
| Device Name | Tube, Bronchial (W/Wo Connector) |
| Regulation | 21 CFR 868.5720 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION | Rusch, Inc. | Nov 27, 1995 | SESE |
| K951091 | RUSCH ENDOBRONCHIAL TUBE SETS | Rusch Intl. | Jun 8, 1995 | SESE |
| K902116 | MODIFIED ENDOBRONCHIAL TUBE | Concord/Portex | Aug 3, 1990 | SESE |
| K834565 | ENDOBRONCHIAL TWIN LUMEN TUBE | Portex, Inc. | Jan 17, 1984 | SESE |
| K833297 | BRONCHOSCOPY TUBE W/ULTRA LOCUFF | Surgitek | Dec 27, 1983 | SESE |
| K771219 | 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
