
Biosphere Medical, Inc.
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EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 is an FDA 510(k)-cleared medical device (K062126) manufactured by Biosphere Medical, 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 August 8, 2006. Regulation: 8.