PHOENIX HEMODIALYSIS DELIVERY SYSTEM— 510(k) K103832
Substantially EquivalentGambro Renal Products, Inc.
FDA 510(k) clearance K103832 for PHOENIX HEMODIALYSIS DELIVERY SYSTEM, Substantially Equivalent on 2011-05-20. Applicant: Gambro Renal Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products, Inc.
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code KDI
view allMore clearances from Gambro Renal Products, Inc.
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
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 K103832
K-number listed on FDA's recall record- Z-1094-2017 — Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
- Z-1095-2017 — Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103832.
Data sourced from openFDA. This site is unofficial and independent of the FDA.