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FDA 510(k)

HEMASITE ACCESSORIES MODIFICATION

K-Number: K840437 · 1984-02-21

ApplicantRenal Systems, Inc.
Decision Date1984-02-21
Product CodeKNZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMASITE ACCESSORIES MODIFICATION 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 1984-02-21 under 510(k) number K840437. The device is classified under product code KNZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMASITE ACCESSORIES MODIFICATION?

HEMASITE ACCESSORIES MODIFICATION is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Renal Systems, Inc.. The 510(k) number is K840437.

When did HEMASITE ACCESSORIES MODIFICATION receive FDA 510(k) clearance?

HEMASITE ACCESSORIES MODIFICATION received FDA 510(k) clearance on 1984-02-21, under 510(k) number K840437.

Who is the listed applicant for HEMASITE ACCESSORIES MODIFICATION?

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 HEMASITE ACCESSORIES MODIFICATION?

The FDA product code for HEMASITE ACCESSORIES MODIFICATION is KNZ.

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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: KNZ)

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.

K842039ARGON DUAL LUMEN HEMODIALYSIS, CATHETERArgon Medical Corp.K844612ACUTE HEMODIALYSIS TRAYSPackaging Technologies, Inc.K842864VACCESS FEMORAL CANNULAVas-Cath of Canada , Ltd.K842416DUO FLOW CATHETER-MC 54Medical Components, Inc.K841530DOUBLE LUMEN SUBLCAVIAN-FEMORALMedical Components, Inc.K841119TOPS DISPOS. INFUSION SET/HEMODIALYSISTop Surgical Manufacturers Co.

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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