510(k) K812563 ยท DYG Catheter, Flow Directed
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
| Applicant | American Edwards Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 25, 1981 |
| Received | Sep 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P.
For use in patients who require hemodynamic monitoring. Terminated |
DYG | None listed |
| Jan 5, 2007 | Edwards Lifesciences Technology SARL Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75 Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.