Northeast Scientific Receives 510(k) Clearance for Reprocessing Catheter

Northeast Scientific has received 510(k) clearance from the FDA for reprocessing the Philips Spectranetics 0.9-millimeter OTW Turbo-Elite laser atherectomy catheter.

The clearance is the first by the FDA for reprocessing this type of atherectomy catheter, which is used to treat peripheral arterial disease. The catheter delivers high energy ultraviolet light to vaporize blockages inside vessels.

Northeast Scientific founder and CEO Craig Allmendinger said the FDA had set a high bar for the company to prove that its reprocessing produced an equivalent device to the original.