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FDA 510(k)

JMS AV FISTULA NEEDLES

K-Number: K911199 · 1991-08-28

ApplicantJms Co., Ltd.
Decision Date1991-08-28
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JMS AV FISTULA NEEDLES 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 1991-08-28 under 510(k) number K911199. 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 AV FISTULA NEEDLES?

JMS AV FISTULA NEEDLES is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Jms Co., Ltd.. The 510(k) number is K911199.

When did JMS AV FISTULA NEEDLES receive FDA 510(k) clearance?

JMS AV FISTULA NEEDLES received FDA 510(k) clearance on 1991-08-28, under 510(k) number K911199.

Who is the listed applicant for JMS AV FISTULA NEEDLES?

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 AV FISTULA NEEDLES?

The FDA product code for JMS AV FISTULA NEEDLES is FIE.

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Other records listing Jms Co., Ltd. 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.

K002352JMS A.V. FISTULA NEEDLE SET ACCORDION TYPEK002394JMS APHERESIS NEEDLE SET ACCORDION TYPEK010410JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18GK010406JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18GK000843MODIFICATION TO JMS APHERESIS NEEDLEK000845MODIFICATION TO JMS A.V. FISTULA NEEDLE SET

View all 24 devices →

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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