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FDA 510(k)

JMS CAVEO A.V. Fistula Needle Set

K-Number: K251877 · 2025-08-15

ApplicantJMS North America Corporation
Decision Date2025-08-15
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JMS CAVEO A.V. Fistula Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is JMS North America Corporation. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251877. 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 CAVEO A.V. Fistula Needle Set?

JMS CAVEO A.V. Fistula Needle Set is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is JMS North America Corporation. The 510(k) number is K251877.

When did JMS CAVEO A.V. Fistula Needle Set receive FDA 510(k) clearance?

JMS CAVEO A.V. Fistula Needle Set received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251877.

Who is the listed applicant for JMS CAVEO A.V. Fistula Needle Set?

The FDA 510(k) record lists JMS North America Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JMS CAVEO A.V. Fistula Needle Set?

The FDA product code for JMS CAVEO A.V. Fistula Needle Set is FIE.

Other records listing JMS North America Corporation 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.

K172499NEOSHIELD

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, LLCK213015DORA 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.

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.

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