
Arrow Intl., Inc.
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PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT is an FDA 510(k)-cleared medical device (K984022) manufactured by Arrow Intl., Inc.. 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 17, 1999. Regulation: 8.