KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.

KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. is an FDA 510(k)-cleared medical device (K921054) manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. 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 September 22, 1992. Regulation: 8.