GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT is an FDA 510(k)-cleared medical device (K070048) manufactured by Marian Medical, 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 March 14, 2007. Regulation: 8.