510(k) K003425 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Feb 1, 2001 |
| Received | Nov 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2005 | Asahi Medical Co Ltd Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within Terminated |
KDI | None listed |
| May 3, 2005 | Asahi Medical Co Ltd Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.