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FDA 510(k)

PLUME FISTULA NEEDLE

K-Number: K841791 · 1984-07-09

ApplicantHospal Medical Corp.
Decision Date1984-07-09
Product CodeFIQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PLUME FISTULA NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Medical Corp.. It received FDA 510(k) clearance on 1984-07-09 under 510(k) number K841791. 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 PLUME FISTULA NEEDLE?

PLUME FISTULA NEEDLE is a medical device that received FDA 510(k) clearance on 1984-07-09. The listed applicant is Hospal Medical Corp.. The 510(k) number is K841791.

When did PLUME FISTULA NEEDLE receive FDA 510(k) clearance?

PLUME FISTULA NEEDLE received FDA 510(k) clearance on 1984-07-09, under 510(k) number K841791.

Who is the listed applicant for PLUME FISTULA NEEDLE?

The FDA 510(k) record lists Hospal Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLUME FISTULA NEEDLE?

The FDA product code for PLUME FISTULA NEEDLE is FIQ.

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Other records listing Hospal Medical Corp. as applicant

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K893742FILTRAL TM 20 HEMODIALYZER/FILTERK884365MULTIFLOW(TM) 60 KITK884326FILTRAL TM 8 HEMODIALYZERK883307CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KITK872767FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZERK871218MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

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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.K840322HEMOFILTRATION CATHETER HF-100Vas-Cath of Canada , Ltd.K840415HEMOCATHQuinton, Inc.

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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