GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L— 510(k) K010985

Substantially Equivalent

Gambro Renal Products

FDA 510(k) clearance K010985 for GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L, Substantially Equivalent on 2001-10-10. Applicant: Gambro Renal Products.

Clearance details

Applicant: Gambro Renal Products
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-02
Decision date: 2001-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.