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Gentuity, LLC FDA Approvals
0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter510(k)Jan 31, 2025Cardiovascular |
| HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))510(k)Aug 16, 2024Radiology |
| Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter510(k)Aug 8, 2023Cardiovascular |