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FDA 510(k)

RENAFLO II

K-Number: K823546 · 1982-12-16

ApplicantRenal Systems, Inc.
Decision Date1982-12-16
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAFLO II 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 1982-12-16 under 510(k) number K823546. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENAFLO II?

RENAFLO II is a medical device that received FDA 510(k) clearance on 1982-12-16. The listed applicant is Renal Systems, Inc.. The 510(k) number is K823546.

When did RENAFLO II receive FDA 510(k) clearance?

RENAFLO II received FDA 510(k) clearance on 1982-12-16, under 510(k) number K823546.

Who is the listed applicant for RENAFLO II?

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 II?

The FDA product code for RENAFLO II is KOC.

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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: KOC)

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.

K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUNIKKISO CO., LTD.K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)NIKKISO CO., LTD.K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD.K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD.K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineFresenius Medical Care Renal Therapies Group, LLCK172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC

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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