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FDA 510(k)

RENALLOY HEMASITE VASCULAR ACCESS SHUNT

K-Number: K833622 · 1983-11-29

ApplicantRenal Systems, Inc.
Decision Date1983-11-29
Product CodeFIQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENALLOY HEMASITE VASCULAR ACCESS SHUNT 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 1983-11-29 under 510(k) number K833622. The device is classified under product code FIQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENALLOY HEMASITE VASCULAR ACCESS SHUNT?

RENALLOY HEMASITE VASCULAR ACCESS SHUNT is a medical device that received FDA 510(k) clearance on 1983-11-29. The listed applicant is Renal Systems, Inc.. The 510(k) number is K833622.

When did RENALLOY HEMASITE VASCULAR ACCESS SHUNT receive FDA 510(k) clearance?

RENALLOY HEMASITE VASCULAR ACCESS SHUNT received FDA 510(k) clearance on 1983-11-29, under 510(k) number K833622.

Who is the listed applicant for RENALLOY HEMASITE VASCULAR ACCESS SHUNT?

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 RENALLOY HEMASITE VASCULAR ACCESS SHUNT?

The FDA product code for RENALLOY HEMASITE VASCULAR ACCESS SHUNT is FIQ.

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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: FIQ)

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.

K892887ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULAAkcess Medical Products, Inc.K892663S-100 ALLEN-BROWN SHUNTAkcess Medical Products, Inc.K892666SAF-T-SHUNT, S-300 SERIESAkcess Medical Products, Inc.K844692PEDIATRIC SIZED HEMOCATH CATHETERQuinton, Inc.K841791PLUME FISTULA NEEDLEHospal Medical Corp.K840322HEMOFILTRATION CATHETER HF-100Vas-Cath of Canada , Ltd.

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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