K242966
- 510(k) number
- K242966
- Device name
- Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
- Applicant
- Gentuity, LLC MA · US
- Product code
- DQO — Catheter, Intravascular, Diagnostic
- Decision date
- 2025-01-31
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242966.pdf
Official FDA record: K242966
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.