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 a medical device manufactured by JMS North America Corporation. It received FDA 510(k) clearance on 2025-08-15 under approval 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. It is manufactured by JMS North America Corporation. The 510(k) number is K251877.
When was JMS CAVEO A.V. Fistula Needle Set approved by the FDA?
JMS CAVEO A.V. Fistula Needle Set received FDA 510(k) clearance on 2025-08-15, under approval number K251877.
What company makes JMS CAVEO A.V. Fistula Needle Set?
JMS CAVEO A.V. Fistula Needle Set is manufactured by JMS North America Corporation.
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.
Related Clinical Trials
Other Devices by JMS North America Corporation
Related Devices (Code: FIE)
K163025DORA 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.
K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) 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.