GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS— 510(k) K042938

Substantially Equivalent

Gambro Renal Products

FDA 510(k) clearance K042938 for GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS, Substantially Equivalent on 2005-01-06. Applicant: Gambro Renal Products.

Clearance details

Applicant: Gambro Renal Products
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2004-10-25
Decision date: 2005-01-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Lakewood, CO, US

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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.