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FDA 510(k)

DIACAP ULTRA DIALYSIS FLUID FILTER

K-Number: K052764 · 2006-06-09

ApplicantB. Braun Medizintechnologie GmbH
Decision Date2006-06-09
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIACAP ULTRA DIALYSIS FLUID FILTER is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Medizintechnologie GmbH. It received FDA 510(k) clearance on 2006-06-09 under 510(k) number K052764. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIACAP ULTRA DIALYSIS FLUID FILTER?

DIACAP ULTRA DIALYSIS FLUID FILTER is a medical device that received FDA 510(k) clearance on 2006-06-09. The listed applicant is B. Braun Medizintechnologie GmbH. The 510(k) number is K052764.

When did DIACAP ULTRA DIALYSIS FLUID FILTER receive FDA 510(k) clearance?

DIACAP ULTRA DIALYSIS FLUID FILTER received FDA 510(k) clearance on 2006-06-09, under 510(k) number K052764.

Who is the listed applicant for DIACAP ULTRA DIALYSIS FLUID FILTER?

The FDA 510(k) record lists B. Braun Medizintechnologie GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIACAP ULTRA DIALYSIS FLUID FILTER?

The FDA product code for DIACAP ULTRA DIALYSIS FLUID FILTER is FKQ.

Related Clinical Trials

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Other records listing B. Braun Medizintechnologie GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K072760SOLCART BK071518DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS

Related Devices (Code: FKQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.K864635FOUR TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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