www.fdanews.com/articles/195450-fda-issues-guidance-on-pta-balloon-and-specialty-catheter-510k-submissions
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FDA Issues Guidance on PTA Balloon and Specialty Catheter 510(k) Submissions
January 10, 2020
The FDA released draft guidance detailing the information devicemakers should include in 510(k) submissions of catheter-based devices intended to treat peripheral vasculature lesions.
The guidelines, which cover class II peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters — including infusion catheters, PTA balloon catheters for in-stent restenosis (ISR) and scoring/cutting balloons — include suggestions on labeling, performance testing, biocompatibility and other issues.
Labeling should include information on indications, contraindications, warnings, product information, directions for use and a summary of clinical trial data, if applicable, the agency said.