510(k) K955461 ยท BTO Tube, Tracheostomy (W/Wo Connector)
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
| Applicant | VBM Medizintechnik GmbH, Roy UT, US |
| Decision | Substantially Equivalent, Mar 19, 1997 |
| Received | Nov 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2011 | VBM Medical Inc. Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sulz a.N. Germany
Allows a safe and atraumatic transtracheal access for ox Terminated |
BTO | None listed |
| Jun 28, 2011 | VBM Medical Inc. Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sul z a.N. Germany
Allows a safe and atraumatic transtracheal access for o Terminated |
BTO | None listed |
| Sep 3, 2009 | Instrumentation Industries Inc Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened.
The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation. Terminated |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.