
Ep Dynamics, Inc.
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AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 is an FDA 510(k)-cleared medical device (K090867) manufactured by Ep Dynamics, 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 July 29, 2009. Regulation: 8.