
Biosense Webster, Inc.
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ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S is an FDA 510(k)-cleared medical device (K061463) 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 August 13, 2006. Regulation: 8.