GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R— 510(k) K010667
Substantially EquivalentGambro Renal Products
FDA 510(k) clearance K010667 for GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R, Substantially Equivalent on 2001-06-04. Applicant: Gambro Renal Products.
Clearance details
- Applicant
- Gambro Renal Products
- Product code
- Code KDI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.