
Nexgen Medical Systems, Inc.
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NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 is an FDA 510(k)-cleared medical device (K090932) manufactured by Nexgen Medical Systems, 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 September 23, 2009. Regulation: 8.