FDA Issues Guidance on PTA Balloon and Specialty Catheter 510(k) Submissions

The FDA released draft guidance detailing the information devicemakers should include in 510(k) submissions of catheter-based devices intended to treat peripheral vasculature lesions.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.