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C.R. Bard, Inc.
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ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 is an FDA 510(k)-cleared medical device (K030627) manufactured by C.R. Bard, 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 22, 2003. Regulation: 8.