Compliance Consultants can submit your balloon catheter for a 510(k). We can operate from the early onset of product development to the marketing release. Percutaneous Transluminal Angioplasty (PTA) Catheter can be performed to treat vessel narrowing. A wire is passed from the femoral artery in the groin (or, at times, from the radial artery or brachial artery in the arm) to beyond the area of the artery that is being treated. A balloon catheter is advanced over the wire to the segment that is to be treated. The end of the catheter contains a small folded balloon. When the balloon is inflated, it compresses the plaque and stretches the artery wall to expand, improving blood flow. Regulation Number 21 CFR 870.1250, Product Code LIT and DQY.