Medical Device Manufacturer · US , Blue Ash , OH

Vein 360, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2019

Recent clearances: Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter, Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter, Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Vein 360, LLC Cardiovascular ✕

3 devices

1-3 of 3

Cleared Oct 24, 2023

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360...

Cardiovascular · 60d

Cleared Aug 25, 2023

Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter

Cardiovascular · 144d

Cleared Jun 06, 2023

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

Cardiovascular · 96d