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FDA 510(k)

HOLLO FIBER DIALYZER

K-Number: K801559 · 1980-10-31

ApplicantRenal Devices, Inc.
Decision Date1980-10-31
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLO FIBER DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Renal Devices, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K801559. 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 HOLLO FIBER DIALYZER?

HOLLO FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Renal Devices, Inc.. The 510(k) number is K801559.

When did HOLLO FIBER DIALYZER receive FDA 510(k) clearance?

HOLLO FIBER DIALYZER received FDA 510(k) clearance on 1980-10-31, under 510(k) number K801559.

Who is the listed applicant for HOLLO FIBER DIALYZER?

The FDA 510(k) record lists Renal Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLLO FIBER DIALYZER?

The FDA product code for HOLLO FIBER DIALYZER is FJI.

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.

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Other records listing Renal Devices, Inc. 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.

K810612HEMOPHRONK802075HOLLOW FIBER DIALYZER HOLDERK790696RDI-1 HOLLOW FIBER DIALYZER

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

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

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