510(k) K961977 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
| Applicant | Kendall Healthcare Products Co. Div.Of Tyco Health, Mansfield MA, US |
| Decision | Substantially Equivalent, Jul 31, 1996 |
| Received | May 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961977
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2015 | Teleflex Medical HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile.
Intended for use in thoracic surgery, bronchospirometry, for t Terminated |
CBI | None listed |
| Nov 2, 2006 | Teleflex Medical Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bronchial intubation; H Terminated |
BTS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.