RenaPure Endotoxin Retentive Filter— 510(k) K231410
Substantially EquivalentEvoqua Water Technologies, LLC
FDA 510(k) clearance K231410 for RenaPure Endotoxin Retentive Filter, Substantially Equivalent on 2023-07-19. Applicant: Evoqua Water Technologies, LLC.
Clearance details
- Applicant
- Evoqua Water Technologies, LLC
- Product code
- Code FIP
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tewksbury, MA, US
Adverse events under product code FIP
product code FIP- Malfunction
- 490
- Total
- 490
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.