PALINDROME H, SI, HSI CHRONIC CATHETER

PALINDROME H, SI, HSI CHRONIC CATHETER is an FDA 510(k)-cleared medical device (K112477) manufactured by Covidien. 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 27, 2011. Regulation: 8.