REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS is an FDA 510(k)-cleared medical device (K062435) manufactured by Spire Biomedical, 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 December 4, 2006. Regulation: 8.