510(k) K944729 ยท BSR Stylet, Tracheal Tube
STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE
| Applicant | Coast Medical, Inc., Orange CA, US |
| Decision | Substantially Equivalent, Dec 21, 1994 |
| Received | Sep 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2015 | Vital Signs Colorado Inc. CareFusion Vital Signs LightWand Stylet.
A device inserted into an endotracheal tube to aid in the intubation procedure. Terminated |
BSR | None listed |
| Apr 30, 2015 | Vital Signs Colorado Inc. Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure. Terminated |
BSR | None listed |
| Sep 21, 2008 | Vital Signs Colorado Inc. Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case. Terminated |
BSR | None listed |
| Sep 21, 2008 | Vital Signs Colorado Inc. Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack. Terminated |
BSR | None listed |
| Sep 21, 2008 | Vital Signs Colorado Inc. Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack. Terminated |
BSR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.