www.fdanews.com/articles/198215-angiodynamics-earns-510k-clearance-and-ce-mark-for-implantable-port
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AngioDynamics Earns 510(k) Clearance and CE Mark for Implantable Port
July 27, 2020
New York-based AngioDynamics said it has received 510(k) clearance from the FDA and a CE mark in Europe for its SmartPort+ implantable port.
The subcutaneous port provides long-term access for blood specimen withdrawal and the administration of fluids to patients.
The company said it will immediately launch the product in the U.S. and Europe.