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Oscor, Inc.
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PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV is an FDA 510(k)-cleared medical device (K031164) manufactured by Oscor, 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 June 18, 2003. Regulation: 8.