
B. Braun/Mcgaw
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IMPACT BALLOON DILATION CATHETER is an FDA 510(k)-cleared medical device (K983373) manufactured by B. Braun/Mcgaw. 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 June 21, 1999. Regulation: 8.