Premarket Notification (510(k)) Submissions of Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters
On 13th January 2020, FDA published a draft guidance for premarket notification (510(k)) submissions of peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters.
This guidance document provides draft recommendations, including bench testing and coating characterizations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). These devices are catheter-based devices intended to treat lesions in the peripheral vasculature. This document provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing of these devices.