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FDA 510(k)

PLUME Y SET

K-Number: K854951 · 1986-01-08

ApplicantHospal Medical Corp.
Decision Date1986-01-08
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PLUME Y SET 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 1986-01-08 under 510(k) number K854951. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLUME Y SET?

PLUME Y SET is a medical device that received FDA 510(k) clearance on 1986-01-08. The listed applicant is Hospal Medical Corp.. The 510(k) number is K854951.

When did PLUME Y SET receive FDA 510(k) clearance?

PLUME Y SET received FDA 510(k) clearance on 1986-01-08, under 510(k) number K854951.

Who is the listed applicant for PLUME Y SET?

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 Y SET?

The FDA product code for PLUME Y SET is FIE.

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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: FIE)

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.

K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLCK251877JMS CAVEO A.V. Fistula Needle SetJMS North America CorporationK213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., 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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