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FDA 510(k)

JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET

K-Number: K030479 · 2003-08-18

ApplicantJms North America Corp.
Decision Date2003-08-18
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET 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 2003-08-18 under 510(k) number K030479. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET?

JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET is a medical device that received FDA 510(k) clearance on 2003-08-18. The listed applicant is Jms North America Corp.. The 510(k) number is K030479.

When did JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET receive FDA 510(k) clearance?

JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET received FDA 510(k) clearance on 2003-08-18, under 510(k) number K030479.

Who is the listed applicant for JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET?

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 JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET?

The FDA product code for JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET is FOZ.

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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: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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