FDA 510(k)

JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE

K-Number: K002352 · 2001-09-06

Decision Date2001-09-06

Product CodeFIE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE is the device name listed in this FDA 510(k) record. The listed applicant is Jms Co., Ltd.. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K002352. 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 JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE?

JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is Jms Co., Ltd.. The 510(k) number is K002352.

When did JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE receive FDA 510(k) clearance?

JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE received FDA 510(k) clearance on 2001-09-06, under 510(k) number K002352.

Who is the listed applicant for JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE?

The FDA 510(k) record lists Jms Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE?

The FDA product code for JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE is FIE.

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Other records listing Jms Co., Ltd. as applicant

K002394JMS APHERESIS NEEDLE SET ACCORDION TYPE K010406JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G K010410JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G K000843MODIFICATION TO JMS APHERESIS NEEDLE K000845MODIFICATION TO JMS A.V. FISTULA NEEDLE SET K991904MODIFICATION OF JMS NEEDLES AND JMS SYRINGES

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Related Devices (Code: FIE)

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, LLC K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation K213015DORA 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.