FDA 510(k)

JMD AV FISTULA NEEDLE (MODIFICATION)

K-Number: K860789 · 1986-03-18

Decision Date1986-03-18

Product CodeFIE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

JMD AV FISTULA NEEDLE (MODIFICATION) 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 1986-03-18 under 510(k) number K860789. 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 JMD AV FISTULA NEEDLE (MODIFICATION)?

JMD AV FISTULA NEEDLE (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1986-03-18. The listed applicant is Jms Co., Ltd.. The 510(k) number is K860789.

When did JMD AV FISTULA NEEDLE (MODIFICATION) receive FDA 510(k) clearance?

JMD AV FISTULA NEEDLE (MODIFICATION) received FDA 510(k) clearance on 1986-03-18, under 510(k) number K860789.

Who is the listed applicant for JMD AV FISTULA NEEDLE (MODIFICATION)?

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 JMD AV FISTULA NEEDLE (MODIFICATION)?

The FDA product code for JMD AV FISTULA NEEDLE (MODIFICATION) is FIE.

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Other records listing Jms Co., Ltd. as applicant

K002352JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE K002394JMS APHERESIS NEEDLE SET ACCORDION TYPE K010410JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G K010406JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G K000843MODIFICATION TO JMS APHERESIS NEEDLE K000845MODIFICATION TO JMS A.V. FISTULA NEEDLE SET

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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

View on FDA Database →

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