pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504— 510(k) K233159
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K233159 for pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504, Substantially Equivalent on 2023-12-01. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- 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
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code KPO
view allMore clearances from Fresenius Medical Care Renal Therapies Group, LLC
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.