Data / Medical devices / Tube, Bronchial (W/Wo Connector)
Tube, Bronchial (W/Wo Connector) (BTS): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Tube, Bronchial (W/Wo Connector) (product code BTS, Class 2, 21 CFR 868.5720). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on November 27, 1995, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BTS
- Device class
- 2
- Regulation
- 868.5720
- Medical specialty
- Anesthesiology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Mexico | 1 |
| Ireland | 1 |
Makers of Tube, Bronchial (W/Wo Connector)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 2 | November 27, 1995 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 1 | August 4, 1977 | 0 | 0 | 0 | api.fda.gov |
| Mallinckrodt Medical | ATHLONE Westmeath, Ireland | Manufacturer | 1 | August 4, 1977 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Specification developer | 1 | June 8, 1995 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 27, 1995. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.