510(k) K070320 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01
| Applicant | Edwards Lifesciences Services GmbH, Stevenage, GB |
| Decision | Substantially Equivalent, Jun 7, 2007 |
| Received | Feb 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070320
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2010 | Edwards Lifesciences, Llc Edwards Lifesciences Aquarius System Model GEF09800. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.