
Terumo Cardiovascular Systems Corp.
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) is an FDA 510(k)-cleared medical device (K090878) manufactured by Terumo Cardiovascular Systems Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 2, 2009. Regulation: 8.