Submitted by kBLASTER Team on
by Globe Newswire
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Turnpike catheters, a new line of catheters designed for use in complex coronary and peripheral interventions. Vascular Solutions expects to launch the Turnpike catheters in January following clinical evaluations to occur in December.
The Turnpike catheters are single-lumen catheters with a shaft constructed from two layers of polymer that encapsulate both a braid and a dual-layer coil. The Turnpike is available in two versions, a Soft Tip and a Hard Tip version, both of which advance over an 0.014" guidewire. The name "Turnpike" describes a unique feature of the catheter that by turning the catheter in a clockwise direction it will advance through the artery (i.e., down the "pike").
Search kBLASTER for FDA 510(k) predicates with effective result management to build your successful 510(k) clearance strategy.
