510(k) K092886 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
WELL LEAD ENDOBRONCHIAL TUBES
| Applicant | Well Lead Instruments, Apollo Beach FL, US |
| Decision | Substantially Equivalent, Mar 11, 2010 |
| Received | Sep 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092886
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2017 | Parker Medical Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1,
H-PFTDL-41-1.
Terminated |
CBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.