
Guidant Cardiac and Vascular Surgery
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EVT EXPANDABLE SHEATH is an FDA 510(k)-cleared medical device (K970470) manufactured by Guidant Cardiac and Vascular Surgery. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 30, 1997. Regulation: 8.

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