FDA Clears to Ra Medical’s DABRA 2.0 Catheter

The FDA granted 510(k) clearance to Ra Medical Systems’ DABRA 2.0 catheter, which is part of the company’s excimer laser system to treat vascular diseases.

The catheter, which has a braided overjacket design that’s intended to improve deliverability and kink resistance when navigating complex anatomy, has a six-month shelf life.

Ra Medical said the device represents an interim step in the company’s plan to develop a guidewire-compatible version of the DABRA catheter, so the newly cleared 2.0 catheter will not immediately be marketed to the public.

“While we are pleased to receive this regulatory clearance, it comes as our board continues its evaluation of strategic alternatives to optimize our company’s path forward in the current challenging economic environment,” said Will McGuire, Ra Medical Systems CEO.