Vascular Solutions (VASC) Receives 501(k) Clearance from U.S. FDA for GuideLiner Catheter
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Vascular Solutions, Inc. (NASDAQ: VASC) today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the GuideLiner catheter in the United States.
The GuideLiner is a unique coaxial "mother and child" guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions' specialty catheter product line. CE mark clearance of the GuideLiner was received and European sales and clinical uses commenced in October, with the U.S. launch of the GuideLiner catheter expected to commence in November through Vascular Solutions' direct sales force.
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