510(k) K151525 ยท FKX System, Peritoneal, Automatic Delivery
Amia Automated PD System with Sharesource
| Applicant | Deka Research and Development, Manchester NH, US |
| Decision | Substantially Equivalent, Oct 9, 2015 |
| Received | Jun 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2023 | Baxter Healthcare Corporation Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 Open, Classified |
FKX | None listed |
| Jun 30, 2021 | BAXTER HEALTHCARE CORPORATION Sharesource Connectivity Platform for Use with the Amia Automated PD System Terminated |
FKX | None listed |
| Jun 30, 2021 | BAXTER HEALTHCARE CORPORATION Kaguya Automated Peritoneal Dialysis System Terminated |
FKX | None listed |
| Dec 11, 2018 | Baxter Healthcare Corporation AMIA Automated Peritoneal Dialysis System
Product Usage:
It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal d Terminated |
FKX | None listed |
| Dec 11, 2018 | Baxter Healthcare Corporation Kaguya Automated Peritoneal Dialysis System
Product Usage:
It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal Terminated |
FKX | None listed |
| Jul 12, 2018 | Baxter Healthcare Corporation power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only) Terminated |
FKX | None listed |
| Sep 1, 2017 | Baxter Healthcare Corp Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 Terminated |
FKX | None listed |
| Feb 16, 2016 | Baxter Healthcare Corp. Automated peritoneal dialysis (APD) cycler Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.