FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB— 510(k) K071387
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K071387 for FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB, Substantially Equivalent on 2007-06-15. Applicant: Fresenius Medical Care North America. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waltham, MA, US
Recent devices under product code KPO
view allMore clearances from Fresenius Medical Care North America
view allAdverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
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 K071387
K-number listed on FDA's recall record- Z-2373-2015 — Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
- Z-1827-2015 — NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
- Z-2686-2014 — Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
- Z-1739-2014 — NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
- Z-1639-2014 — Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071387.
Data sourced from openFDA. This site is unofficial and independent of the FDA.