GAMBRO CARTRIDGE BLOOD SETS— 510(k) K070414
Substantially EquivalentGambro Renal Products
FDA 510(k) clearance K070414 for GAMBRO CARTRIDGE BLOOD SETS, Substantially Equivalent on 2007-10-12. Applicant: Gambro Renal Products. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products
- Product code
- Code FJK
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code FJK
view allMore clearances from Gambro Renal Products
view allAdverse events under product code FJK
product code FJK- Death
- 52
- Malfunction
- 3,430
- Total
- 3,482
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K070414
K-number listed on FDA's recall record- Z-1684-2021 — Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Z-1118-2021 — 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.
- Z-1119-2021 — 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.
- Z-1120-2021 — 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.
- Z-1121-2021 — 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.
- Z-1122-2021 — 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 Delivery Systems.
- Z-2193-2020 — Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Z-2194-2020 — Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Z-2195-2020 — 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.
- Z-2196-2020 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070414.
Data sourced from openFDA. This site is unofficial and independent of the FDA.