510(k) K924661 ยท KRA Catheter, Continuous Flush
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Apr 8, 1993 |
| Received | Sep 15, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75
For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipme Terminated |
KRA | None listed |
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75
For use inpatients Terminated |
KRA | None listed |
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating)
REF: 139HF75P
For use inpatients who require hemodynamic monitoring. Intended to be Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.