FDA 510(k)

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX

K-Number: K041726 · 2004-07-23

Decision Date2004-07-23

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Medical Co., Ltd.. It received FDA 510(k) clearance on 2004-07-23 under 510(k) number K041726. 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 HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX?

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Asahi Medical Co., Ltd.. The 510(k) number is K041726.

When did HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX receive FDA 510(k) clearance?

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX received FDA 510(k) clearance on 2004-07-23, under 510(k) number K041726.

Who is the listed applicant for HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX?

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

What is the FDA product code for HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX?

The FDA product code for HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX is KDI.

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Other records listing Asahi Medical Co., Ltd. as applicant

K013418AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY K001250APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X K983720ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-K970650ASAHI AM-R SERIES DIALYZERS K914020MODIFIED ASAHI PAN-SERIES HEMOFILTERS

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Related Devices (Code: KDI)

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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.