
Baxter Healthcare Corp
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4.5F IMAGECATH ANGIOSCOPE is an FDA 510(k)-cleared medical device (K905083) manufactured by Baxter Healthcare Corp. 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 20, 1991. Regulation: 8.