Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ASAHI REXEED-SX/LX SERIES DIALYZER

K-Number: K121409 · 2013-02-06

ApplicantAsahi Kasei Medical Co., Ltd.
Decision Date2013-02-06
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASAHI REXEED-SX/LX 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 2013-02-06 under 510(k) number K121409. 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 SERIES DIALYZER?

ASAHI REXEED-SX/LX SERIES DIALYZER is a medical device that received FDA 510(k) clearance on 2013-02-06. The listed applicant is Asahi Kasei Medical Co., Ltd.. The 510(k) number is K121409.

When did ASAHI REXEED-SX/LX SERIES DIALYZER receive FDA 510(k) clearance?

ASAHI REXEED-SX/LX SERIES DIALYZER received FDA 510(k) clearance on 2013-02-06, under 510(k) number K121409.

Who is the listed applicant for ASAHI REXEED-SX/LX 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 REXEED-SX/LX SERIES DIALYZER?

The FDA product code for ASAHI REXEED-SX/LX SERIES DIALYZER 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 DialyzerK082515ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LXK051187REXEED 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

View on FDA Database →

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

↑