510(k) K160084 ยท DYG Catheter, Flow Directed
Swan Ganz Catheters
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 3, 2016 |
| Received | Jan 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2019 | Edwards Lifesciences, LLC Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J
Product Usage:
The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pres Terminated |
DYG | None listed |
| Jan 31, 2019 | Edwards Lifesciences, LLC Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7)
Product Usage:
The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determin Terminated |
DYG | None listed |
| Jan 31, 2019 | Edwards Lifesciences, LLC Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P
Product Usage:
The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pre Terminated |
DYG | None listed |
| Jan 31, 2019 | Edwards Lifesciences, LLC Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7
Product Usage:
The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic press Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.