JMS Harmony A.V. Fistula Needle Set

JMS Harmony A.V. Fistula Needle Set is an FDA 510(k)-cleared medical device (K151017) manufactured by JMS North America Corporation. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2015. Regulation: 8.