510(k) K100364 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Nov 3, 2010 |
| Received | Feb 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2020 | Baxter Healthcare Corporation Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dia 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.