510(k) K924452 ยท DYG Catheter, Flow Directed
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Oct 29, 1993 |
| Received | Sep 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC THROMBOSHIELD (an Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One cathete 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.