
Bridgepoint Medical
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BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER is an FDA 510(k)-cleared medical device (K111963) manufactured by Bridgepoint Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 2011. Regulation: 8.