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FDA 510(k)

HOLLOW FIBER DIALYZERS

K-Number: K820743 · 1982-06-23

ApplicantTerumo Medical Corp.
Decision Date1982-06-23
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1982-06-23 under 510(k) number K820743. 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 HOLLOW FIBER DIALYZERS?

HOLLOW FIBER DIALYZERS is a medical device that received FDA 510(k) clearance on 1982-06-23. The listed applicant is Terumo Medical Corp.. The 510(k) number is K820743.

When did HOLLOW FIBER DIALYZERS receive FDA 510(k) clearance?

HOLLOW FIBER DIALYZERS received FDA 510(k) clearance on 1982-06-23, under 510(k) number K820743.

Who is the listed applicant for HOLLOW FIBER DIALYZERS?

The FDA 510(k) record lists Terumo Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLLOW FIBER DIALYZERS?

The FDA product code for HOLLOW FIBER DIALYZERS is FJI.

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Other records listing Terumo Medical Corp. as applicant

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Related Devices (Code: FJI)

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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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