
B&K Medical
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K-KATH URETHRAL CATHETER INTRODUCER is an FDA 510(k)-cleared medical device (K802878) manufactured by B&K Medical. 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 January 1, 1981. Regulation: 8.