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FDA 510(k)

RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS

K-Number: K883748 · 1989-01-31

ApplicantKawasumi Laboratories Co., Ltd.
Decision Date1989-01-31
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories Co., Ltd.. It received FDA 510(k) clearance on 1989-01-31 under 510(k) number K883748. 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 RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS?

RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS is a medical device that received FDA 510(k) clearance on 1989-01-31. The listed applicant is Kawasumi Laboratories Co., Ltd.. The 510(k) number is K883748.

When did RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS receive FDA 510(k) clearance?

RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS received FDA 510(k) clearance on 1989-01-31, under 510(k) number K883748.

Who is the listed applicant for RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS?

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

What is the FDA product code for RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS?

The FDA product code for RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS is FJI.

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Other records listing Kawasumi Laboratories 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.

K994323KAWASUMI LABORATORIES PHILEBOTOMY SETK974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITEK935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDERK935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTERK935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION

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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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