Globe Newswire08.24.20
Northeast Scientific Inc., has received U.S. Food and Drug Administration (FDA) 510(k) clearance for reprocessing the .014 Digital IVUS catheter. This is the second 510(k) the Connecticut-based company has been awarded for the reprocessing of the IVUS type catheter.
While crediting his team in their work addressing the FDA requirements to win the 510(k), CEO Craig Allmendinger said; “By adding the .014 IVUS to our existing portfolio of products, we are positioned to be the key resource for any OBL physician focused on keeping costs down while never compromising on patient safety. Adding the .014 in conjunction with the ongoing R&D projects we are working on for other devices, Northeast Scientific is going to continue to separate itself as the world leader in reprocessing for the peripheral vascular market.”
The company will have an additional announcement soon regarding when the .014 device will be available for sale.
With a record for quality and safety across its 15 years of business, Northeast Scientific has reprocessed over 650,000 devices.
While crediting his team in their work addressing the FDA requirements to win the 510(k), CEO Craig Allmendinger said; “By adding the .014 IVUS to our existing portfolio of products, we are positioned to be the key resource for any OBL physician focused on keeping costs down while never compromising on patient safety. Adding the .014 in conjunction with the ongoing R&D projects we are working on for other devices, Northeast Scientific is going to continue to separate itself as the world leader in reprocessing for the peripheral vascular market.”
The company will have an additional announcement soon regarding when the .014 device will be available for sale.
With a record for quality and safety across its 15 years of business, Northeast Scientific has reprocessed over 650,000 devices.
