
Ep Technologies, Inc.
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POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D is an FDA 510(k)-cleared medical device (K003452) manufactured by Ep Technologies, 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 December 6, 2000. Regulation: 8.