PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET— 510(k) K011221

Substantially Equivalent

Gambro Renal Products

FDA 510(k) clearance K011221 for PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET, Substantially Equivalent on 2001-10-31. Applicant: Gambro Renal Products.

Clearance details

Applicant: Gambro Renal Products
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-20
Decision date: 2001-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
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.