Medical Device Manufacturer · US , Waterbury , CT

Northeast Scientific, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2007

Recent clearances: NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700), NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Northeast Scientific, Inc. Cardiovascular ✕

4 devices

1-4 of 4

Cleared May 12, 2025

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

Cardiovascular · 74d

Cleared Feb 03, 2023

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

Cardiovascular · 127d

Cleared Jul 01, 2022

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

Cardiovascular · 161d

Cleared Jun 22, 2020

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

Cardiovascular · 147d