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FDA 510(k)

NEW AM-SERIES DIALYZERS

K-Number: K892374 · 1989-05-18

ApplicantAsahi Medical Co., Ltd.
Decision Date1989-05-18
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEW AM-SERIES DIALYZERS 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 1989-05-18 under 510(k) number K892374. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW AM-SERIES DIALYZERS?

NEW AM-SERIES DIALYZERS is a medical device that received FDA 510(k) clearance on 1989-05-18. The listed applicant is Asahi Medical Co., Ltd.. The 510(k) number is K892374.

When did NEW AM-SERIES DIALYZERS receive FDA 510(k) clearance?

NEW AM-SERIES DIALYZERS received FDA 510(k) clearance on 1989-05-18, under 510(k) number K892374.

Who is the listed applicant for NEW AM-SERIES DIALYZERS?

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 NEW AM-SERIES DIALYZERS?

The FDA product code for NEW AM-SERIES DIALYZERS is FJI.

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Other records listing Asahi 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.

K041726HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EXK013418AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRYK001250APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-XK983720ASAHI 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

View all 16 devices →

Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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.

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