Gentuity, LLC - FDA 510(k) Cleared Devices
Recent clearances: Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter, HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)), Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gentuity, LLC Cardiovascular ✕
4 devices
Cleared
Jan 31, 2025
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
Cardiovascular
127d
Cleared
Aug 16, 2024
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT...
Cardiovascular
17d
Cleared
Aug 08, 2023
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
Cardiovascular
155d
Cleared
Feb 20, 2020
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Cardiovascular
127d