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Diacap Pro Dialyzer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K170574

by B.Braun Avitum AG

Identifiers

510(k) Number
K170574 FDA 510(k)
FDA Product Code
KDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5860 FDA 510(k)
Regulation Number
876.5860 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Diacap Pro Dialyzer is a high-permeability dialyzer designed for hemodialysis treatment. It facilitates the removal of waste products, excess fluids, and electrolytes from the blood of patients with renal failure by diffusing and ultrafiltration processes through a semipermeable membrane.

Supplied as a single-use device, the Diacap Pro Dialyzer is intended for use in clinical settings such as dialysis centers. It is regulated under FDA 510K clearance and the EU Medical Device Regulation (MDR), with multiple FEI numbers and registration identifiers listed. The device is non-sterile before use and must be sterilized by the manufacturer prior to packaging. It is available in various sizes and configurations, as indicated by the listed FEI numbers, and requires proper storage to maintain integrity until use.

Frequently asked questions

What clinical conditions is the Diacap Pro Dialyzer primarily intended to address in patients?

The Diacap Pro Dialyzer is designed for hemodialysis treatment, which removes waste products, excess fluids, and electrolytes from the blood of patients with renal failure. It uses diffusion and ultrafiltration through a semipermeable membrane to support patients whose kidneys are no longer functioning adequately.

Is the Diacap Pro Dialyzer single-use or reusable, and how should it be handled before use?

The Diacap Pro Dialyzer is a single-use device. It is supplied non-sterile and must be sterilized by the manufacturer prior to packaging, ensuring it is sterile when ready for clinical use. This means each unit is intended for one-time use only and cannot be reused after a single procedure.

What regulatory pathways has the Diacap Pro Dialyzer followed for market authorization, and where is it currently available?

The Diacap Pro Dialyzer has undergone FDA 510(k) clearance and is authorized under the EU Medical Device Regulation (MDR). It is intended for use in clinical settings like dialysis centers, with multiple FEI numbers and registration identifiers confirming its regulatory compliance in both the U.S. and EU markets.

How many different sizes or configurations are available for the Diacap Pro Dialyzer, and how can I identify them?

The Diacap Pro Dialyzer is available in multiple sizes and configurations, each corresponding to specific FEI numbers (e.g., 3033903155, 3002806443, etc.). These identifiers help distinguish between models, ensuring compatibility with patient needs and dialysis protocols. The exact specifications for each size are detailed in the manufacturer’s documentation.

What storage requirements should be followed to maintain the integrity of the Diacap Pro Dialyzer before use?

The Diacap Pro Dialyzer must be stored under conditions that preserve its integrity until use. While the exact storage instructions are manufacturer-specific, typical guidelines for single-use medical devices include protection from physical damage, contamination, and extreme temperatures. Always refer to the packaging or manufacturer’s instructions for precise storage protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
B.Braun Avitum AG
FDA Applicant
B. Braun Avitum AG

Sources (2)

  • FDA 510(k) K170574 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026