510(k) K043065 ยท DRS Transducer, Blood-Pressure, Extravascular
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 26, 2005 |
| Received | Nov 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2013 | Edwards Lifesciences, LLC "***Flo Trac Sensor Model MHD85***"
Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. Terminated |
DRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.