510(k) K810352 ยท DYG Catheter, Flow Directed
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
| Applicant | American Edwards Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 27, 1981 |
| Received | Feb 10, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810352
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.