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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 the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Avitum AG. It received FDA 510(k) clearance on 2017-08-11 under 510(k) 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. The listed applicant is B. Braun Avitum AG. The 510(k) number is K170574.

When did Diacap Pro Dialyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for Diacap Pro Dialyzer?

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

What is the FDA product code for Diacap Pro Dialyzer?

The FDA product code for Diacap Pro Dialyzer is KDI.

Other records listing B. Braun Avitum AG 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.

PMA P940016Lipoprotein, low density, removalK143482xevonta dialyzer

Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

Official Source

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

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