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FDA 510(k)

RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.

K-Number: K801825 · 1980-09-26

ApplicantRenal Systems, Inc.
Decision Date1980-09-26
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. is the device name listed in this FDA 510(k) record. The listed applicant is Renal Systems, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K801825. 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 RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.?

RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Renal Systems, Inc.. The 510(k) number is K801825.

When did RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. receive FDA 510(k) clearance?

RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. received FDA 510(k) clearance on 1980-09-26, under 510(k) number K801825.

Who is the listed applicant for RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.?

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

What is the FDA product code for RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.?

The FDA product code for RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. is FJI.

Related Clinical Trials

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Other records listing Renal Systems, 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.

K970648PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)K861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTK854011RENALFO HEMOFILTER CAVHDK844790RENAFLO HEMOCONCENTRATORK843963DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDK844108RENAL SYSTEMS PERITONEAL ACCESS SYSTEM

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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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