
Biosense Webster, Inc.
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CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR is an FDA 510(k)-cleared medical device (K050877) 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 23, 2005. Regulation: 8.