B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT

B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT is an FDA 510(k)-cleared medical device (K955381) manufactured by B.Braun Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 1996. Regulation: 8.