Submitted by kBLASTER Team on
by Business Wire
SAN CLEMENTE, Calif.–(BUSINESS WIRE)—ReFlow Medical, Inc. (ReFlow) today announced FDA 510(k) clearance for US commercialization of their speX™ Shapeable Support Catheter for use in the peripheral vasculature as well as the first US clinical cases with the device. The initial US cases were performed by Dr. John R. Laird at the UC Davis Vascular Center in Davis, California. The speX™ Shapeable Support Catheter enables physicians to shape the tip of the support catheter to their preferred angle to meet the specific needs of the case and maintain that angle throughout the procedure. It is designed to be compatible with physician preferred .035 guidewires and the Wingman14 Crossing Catheters.
Go to kBLASTER for FDA 510(k) predicate search with effective result management to build your successful 510(k) clearance strategy.