
Datascope Corp.
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CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX is an FDA 510(k)-cleared medical device (K031636) manufactured by Datascope Corp.. 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 10, 2003. Regulation: 8.

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