
Sorensen Research
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A.V. FISTULA NEEDLE SET (#344) is an FDA 510(k)-cleared medical device (K771490) manufactured by Sorensen Research. 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 August 15, 1977. Regulation: 8.