510(k) K042683 ยท BTR Tube, Tracheal (W/Wo Connector)
WELL LEAD ENDOTRACHEAL TUBE
| Applicant | Well Lead Medical Instruments, Apollo Beach FL, US |
| Decision | Substantially Equivalent, Feb 18, 2005 |
| Received | Sep 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042683
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | WELL LEAD MEDICAL CO. LTD SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 Open, Classified |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.