
Biosense Webster, Inc.
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PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M is an FDA 510(k)-cleared medical device (K001139) manufactured by Biosense Webster, 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 9, 2000. Regulation: 8.