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FDA 510(k)

PLUME SAFETY AVF NEEDLE

K-Number: K040247 · 2004-03-03

ApplicantJms North America Corp.
Decision Date2004-03-03
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PLUME SAFETY AVF NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Jms North America Corp.. It received FDA 510(k) clearance on 2004-03-03 under 510(k) number K040247. 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 SAFETY AVF NEEDLE?

PLUME SAFETY AVF NEEDLE is a medical device that received FDA 510(k) clearance on 2004-03-03. The listed applicant is Jms North America Corp.. The 510(k) number is K040247.

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

PLUME SAFETY AVF NEEDLE received FDA 510(k) clearance on 2004-03-03, under 510(k) number K040247.

Who is the listed applicant for PLUME SAFETY AVF NEEDLE?

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

What is the FDA product code for PLUME SAFETY AVF NEEDLE?

The FDA product code for PLUME SAFETY AVF NEEDLE is FIE.

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Other records listing Jms North America Corp. 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.

K093637JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300K082882A.V. FISTULA BLUNT NEEDLE SETK070234JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETSK070143JMS PLANECTA STOPCOCKK051814JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SETK032975JMS BLOOD TUBING SETS

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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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