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FDA 510(k)

Diacap Pro Dialyzer

K-Number: K170574 · 2017-08-11

ApplicantB. Braun Avitum AG
Decision Date2017-08-11
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Diacap Pro Dialyzer is a medical device manufactured by B. Braun Avitum AG. It received FDA 510(k) clearance on 2017-08-11 under approval number K170574. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diacap Pro Dialyzer?

Diacap Pro Dialyzer is a medical device that received FDA 510(k) clearance on 2017-08-11. It is manufactured by B. Braun Avitum AG. The 510(k) number is K170574.

When was Diacap Pro Dialyzer approved by the FDA?

Diacap Pro Dialyzer received FDA 510(k) clearance on 2017-08-11, under approval number K170574.

What company makes Diacap Pro Dialyzer?

Diacap Pro Dialyzer is manufactured by B. Braun Avitum AG.

What is the FDA product code for Diacap Pro Dialyzer?

The FDA product code for Diacap Pro Dialyzer is KDI.

Other Devices by B. Braun Avitum AG

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Related Devices (Code: KDI)

K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl K160881Tablo ConsoleOutset Medical, Inc. K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, 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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