510(k) K010131 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
| Applicant | Aksys, Ltd., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Mar 26, 2002 |
| Received | Jan 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010131
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2006 | Aksys, Ltd. Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high permeability hemodialysis system, water purification system for hemodialysis; Manufactured in the USA for Aksys Lt Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.