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FDA 510(k)

ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX

K-Number: K082515 · 2008-10-03

ApplicantAsahi Kasei Medical Co., Ltd.
Decision Date2008-10-03
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX 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 2008-10-03 under 510(k) number K082515. 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 REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX?

ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX is a medical device that received FDA 510(k) clearance on 2008-10-03. The listed applicant is Asahi Kasei Medical Co., Ltd.. The 510(k) number is K082515.

When did ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX receive FDA 510(k) clearance?

ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX received FDA 510(k) clearance on 2008-10-03, under 510(k) number K082515.

Who is the listed applicant for ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX?

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 REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX?

The FDA product code for ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX is KDI.

Related Clinical Trials

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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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.

K162248Asahi ViE-U Series DialyzerK121409ASAHI REXEED-SX/LX SERIES DIALYZERK051187REXEED SERIES DIALYZERS

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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