
Medtronic Vascular
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ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A is an FDA 510(k)-cleared medical device (K021587) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2002. Regulation: 8.