JMS Harmony A.V. Fistula Needle Set

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K151017 ↗

FDA Product Code

FIE

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K110157 Active Cleared 11 Feb 2011

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See all devices from JMS North America Corporation →