510(k) K915726 ยท DQO Catheter, Intravascular, Diagnostic
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Sep 21, 1992 |
| Received | Dec 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915726
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7.
For use in patients who require hemodynamic monitoring. Terminated |
DQO | None listed |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J.
For use in patients who require hemodynamic monitoring. Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.