
Boston Scientific Scimed, Inc.
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PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE is an FDA 510(k)-cleared medical device (K030617) manufactured by Boston Scientific Scimed, 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 May 20, 2003. Regulation: 8.