510(k) K940795 ยท DYG Catheter, Flow Directed
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
| Applicant | Baxter Edwards, Irvine CA, US |
| Decision | Substantially Equivalent, May 24, 1994 |
| Received | Feb 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2015 | Edwards Lifesciences, LLC Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic vo Terminated |
DYG | None listed |
| Aug 2, 2006 | Edwards Lifesciences Llc EDWARDS VIGILANCE MONITORS
(FORMERLY BAXTER VIGILANCE MONITORS)
with software release 5.3 or earlier only. Patient monitor which measures cardiac output.
Models: VG, VGS, VGS1, VGS2, VG2, & IVM. Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.