FDA 510(k)

JMS APHERESIS NEEDLE SET ACCORDION TYPE

K-Number: K002394 · 2001-09-05

Decision Date2001-09-05

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

JMS APHERESIS 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 2001-09-05 under 510(k) number K002394. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JMS APHERESIS NEEDLE SET ACCORDION TYPE?

JMS APHERESIS NEEDLE SET ACCORDION TYPE is a medical device that received FDA 510(k) clearance on 2001-09-05. The listed applicant is Jms Co., Ltd.. The 510(k) number is K002394.

When did JMS APHERESIS NEEDLE SET ACCORDION TYPE receive FDA 510(k) clearance?

JMS APHERESIS NEEDLE SET ACCORDION TYPE received FDA 510(k) clearance on 2001-09-05, under 510(k) number K002394.

Who is the listed applicant for JMS APHERESIS 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 APHERESIS NEEDLE SET ACCORDION TYPE?

The FDA product code for JMS APHERESIS NEEDLE SET ACCORDION TYPE is FMI.

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Other records listing Jms Co., Ltd. as applicant

K002352JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE K010406JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G K010410JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G K000845MODIFICATION TO JMS A.V. FISTULA NEEDLE SET K000843MODIFICATION TO JMS APHERESIS NEEDLE K991904MODIFICATION OF JMS NEEDLES AND JMS SYRINGES

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Related Devices (Code: FMI)

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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.