Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate— 510(k) K212620
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K212620 for Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate, Substantially Equivalent on 2022-05-12. Applicant: Fresenius Medical Care Renal Therapies Group, LLC.
Clearance details
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Product code
- Code KPO
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.