
Biosense Webster, Inc.
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SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 is an FDA 510(k)-cleared medical device (K101138) manufactured by Biosense Webster, 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 June 21, 2010. Regulation: 8.

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