DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS— 510(k) K071518

Substantially Equivalent

B. Braun Medizintechnologie GmbH

FDA 510(k) clearance K071518 for DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS, Substantially Equivalent on 2007-08-17. Applicant: B. Braun Medizintechnologie GmbH.

Clearance details

Applicant: B. Braun Medizintechnologie GmbH
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2007-06-04
Decision date: 2007-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melsungen, DE

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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.