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FDA 510(k)

RENAFLO HEMOCONCENTRATOR

K-Number: K844790 · 1985-05-23

ApplicantRenal Systems, Inc.
Decision Date1985-05-23
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAFLO HEMOCONCENTRATOR 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 1985-05-23 under 510(k) number K844790. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENAFLO HEMOCONCENTRATOR?

RENAFLO HEMOCONCENTRATOR is a medical device that received FDA 510(k) clearance on 1985-05-23. The listed applicant is Renal Systems, Inc.. The 510(k) number is K844790.

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

RENAFLO HEMOCONCENTRATOR received FDA 510(k) clearance on 1985-05-23, under 510(k) number K844790.

Who is the listed applicant for RENAFLO HEMOCONCENTRATOR?

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 HEMOCONCENTRATOR?

The FDA product code for RENAFLO HEMOCONCENTRATOR is KDI.

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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 CAVHDK844108RENAL SYSTEMS PERITONEAL ACCESS SYSTEMK843963DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDK842258RENATRON

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius 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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