TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS

TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS is an FDA 510(k)-cleared medical device (K002902) manufactured by The Kendall Company. 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 April 8, 2001. Regulation: 8.