Product code BTS
- Device name
- Tube, Bronchial (W/Wo Connector)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5720
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953963 | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION | Rusch, Inc. | 1995-11-27 |
| K951091 | RUSCH ENDOBRONCHIAL TUBE SETS | Rusch Intl. | 1995-06-08 |
| K902116 | MODIFIED ENDOBRONCHIAL TUBE | Concord/Portex | 1990-08-03 |
| K834565 | ENDOBRONCHIAL TWIN LUMEN TUBE | Portex, Inc. | 1984-01-17 |
| K833297 | BRONCHOSCOPY TUBE W/ULTRA LOCUFF | Surgitek | 1983-12-27 |
| K771219 | BRONCHO-CATH | Mallinckrodt Critical Care | 1977-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884521831780 | Shiley | Covidien LP | 2023-03-30 |
| 20884521831787 | Shiley | Covidien LP | 2023-03-30 |
| 10884521831674 | Shiley | Covidien LP | 2023-02-20 |
| 10884521831681 | Shiley | Covidien LP | 2023-02-20 |
| 20884521831688 | Shiley | Covidien LP | 2023-02-20 |
| 20884521831671 | Shiley | Covidien LP | 2023-02-20 |
| 20884521831664 | Shiley | Covidien LP | 2023-02-19 |
| 10884521831667 | Shiley | Covidien LP | 2023-02-19 |
| 10884521831650 | Shiley | Covidien LP | 2023-02-18 |
| 20884521831657 | Shiley | Covidien LP | 2023-02-18 |
| 10884521831537 | Shiley | Covidien LP | 2023-02-16 |
| 20884521831534 | Shiley | Covidien LP | 2023-02-16 |
| 10884521831803 | Shiley | Covidien LP | 2023-02-06 |
| 10884521831797 | Shiley | Covidien LP | 2023-02-06 |
| 10884521831773 | Shiley | Covidien LP | 2023-02-06 |
| 10884521831582 | Shiley | Covidien LP | 2023-02-06 |
| 10884521831575 | Shiley | Covidien LP | 2023-02-06 |
| 10884521831551 | Shiley | Covidien LP | 2023-02-06 |
| 10884521831544 | Shiley | Covidien LP | 2023-02-06 |
| 10884521831568 | Shiley | Covidien LP | 2023-02-05 |
| 10884522008785 | Shiley | Covidien LP | 2018-03-21 |
| 24026704008814 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 24026704008821 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 24026704008838 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 24026704008845 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 24026704009361 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 04026704065264 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 24026704009392 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 24026704009385 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 24026704009378 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |