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FDA 510(k)

HEMASITE VASCULAR ACCESS SHUNT HM-1000

K-Number: K813237 · 1981-11-30

ApplicantRenal Systems, Inc.
Decision Date1981-11-30
Product CodeFIQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMASITE VASCULAR ACCESS SHUNT HM-1000 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 1981-11-30 under 510(k) number K813237. 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 HEMASITE VASCULAR ACCESS SHUNT HM-1000?

HEMASITE VASCULAR ACCESS SHUNT HM-1000 is a medical device that received FDA 510(k) clearance on 1981-11-30. The listed applicant is Renal Systems, Inc.. The 510(k) number is K813237.

When did HEMASITE VASCULAR ACCESS SHUNT HM-1000 receive FDA 510(k) clearance?

HEMASITE VASCULAR ACCESS SHUNT HM-1000 received FDA 510(k) clearance on 1981-11-30, under 510(k) number K813237.

Who is the listed applicant for HEMASITE VASCULAR ACCESS SHUNT HM-1000?

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 VASCULAR ACCESS SHUNT HM-1000?

The FDA product code for HEMASITE VASCULAR ACCESS SHUNT HM-1000 is FIQ.

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Other records listing Renal Systems, Inc. as applicant

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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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