DIACAP ULTRA DIALYSIS FLUID FILTER— 510(k) K052764

Substantially Equivalent

B. Braun Medizintechnologie GmbH

FDA 510(k) clearance K052764 for DIACAP ULTRA DIALYSIS FLUID FILTER, Substantially Equivalent on 2006-06-09. Applicant: B. Braun Medizintechnologie GmbH.

Clearance details

Applicant: B. Braun Medizintechnologie GmbH
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 2005-09-30
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melsungen, DE

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Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.