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FDA 510(k)

Asahi ViE-U Series Dialyzer

K-Number: K162248 · 2017-05-03

ApplicantAsahi Kasei Medical Co., Ltd.
Decision Date2017-05-03
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Asahi ViE-U Series Dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Kasei Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K162248. 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 Asahi ViE-U Series Dialyzer?

Asahi ViE-U Series Dialyzer is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Asahi Kasei Medical Co., Ltd.. The 510(k) number is K162248.

When did Asahi ViE-U Series Dialyzer receive FDA 510(k) clearance?

Asahi ViE-U Series Dialyzer received FDA 510(k) clearance on 2017-05-03, under 510(k) number K162248.

Who is the listed applicant for Asahi ViE-U Series Dialyzer?

The FDA 510(k) record lists Asahi Kasei Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Asahi ViE-U Series Dialyzer?

The FDA product code for Asahi ViE-U Series Dialyzer is KDI.

Other records listing Asahi Kasei Medical Co., Ltd. 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.

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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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