DIACAP ULTRA DIALYSIS FLUID FILTER— 510(k) K052764

Name: FDA 510(k) clearance K052764
Creator: U.S. Food and Drug Administration
Published: 2006-06-09

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. Device class: 2.

Clearance details

Applicant: B. Braun Medizintechnologie GmbH
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2005-09-30
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melsungen, DE

Download summary PDF View on FDA.gov ↗

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More clearances from B. Braun Medizintechnologie GmbH

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K072760 — SOLCART B2008-01-29
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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 →

Recalls naming K052764

K-number listed on FDA's recall record

Z-1183-2013 — Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.Class II·Terminated·B. Braun Medical, Inc.·20130301

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052764.

Data sourced from openFDA. This site is unofficial and independent of the FDA.