510(k) K070414 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
GAMBRO CARTRIDGE BLOOD SETS
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Oct 12, 2007 |
| Received | Feb 12, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2021 | Baxter Healthcare Corporation Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. Terminated |
FJK | None listed |
| Dec 30, 2020 | Baxter Healthcare Corporation Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. Open, Classified |
FJK | None listed |
| Dec 30, 2020 | Baxter Healthcare Corporation Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. Open, Classified |
FJK | None listed |
| Dec 30, 2020 | Baxter Healthcare Corporation Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems Open, Classified |
FJK | None listed |
| Dec 30, 2020 | Baxter Healthcare Corporation Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems Open, Classified |
FJK | None listed |
| Dec 30, 2020 | Baxter Healthcare Corporation Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Deliv Open, Classified |
FJK | None listed |
| Apr 17, 2020 | Baxter Healthcare Corporation Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Terminated |
FJK | None listed |
| Apr 17, 2020 | Baxter Healthcare Corporation Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Terminated |
FJK | None listed |
| Apr 17, 2020 | Baxter Healthcare Corporation Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Terminated |
FJK | None listed |
| Apr 17, 2020 | Baxter Healthcare Corporation Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Terminated |
FJK | None listed |
| Sep 26, 2008 | Gambro Renal Products, Inc. Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems. Terminated |
FJK | None listed |
| Sep 26, 2008 | Gambro Renal Products, Inc. Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems. Terminated |
FJK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.