510(k) K131254 ยท BTR Tube, Tracheal (W/Wo Connector)
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
| Applicant | Kimberly-Clark Corp., Roswell GA, US |
| Decision | Substantially Equivalent, Aug 20, 2013 |
| Received | May 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131254
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | None listed |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC.
Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | None listed |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC.
Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | None listed |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC.
Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | None listed |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC.
Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.