
Vanguard Medical Concepts, Inc.
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VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS is an FDA 510(k)-cleared medical device (K022316) manufactured by Vanguard Medical Concepts, 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 October 9, 2002. Regulation: 8.