510(k) K934742 ยท DYG Catheter, Flow Directed
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Jan 24, 1994 |
| Received | Oct 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934742
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746F8
For use in Terminated |
DYG | None listed |
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One cat Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.