510(k) K110269 ยท BTR Tube, Tracheal (W/Wo Connector)
WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
| Applicant | Well Lead Medical Co., Ltd., Appollo Beach FL, US |
| Decision | Substantially Equivalent, Aug 26, 2011 |
| Received | Jan 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110269
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Sub-G Endotracheal Tube with Subglottic Suctioning:
(1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID;
(2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID;
(3) REF DYNJ18870, Polyurethane Cuff 7.0 mm Open, Classified |
BTR | None listed |
| Jul 19, 2016 | Parker Medical Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box.
Product Usage:
The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating pat Terminated |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.