Device details
FDA 510(k) registration fields
- K number
- K162914
- Device name
- VenaCure EVLT NeverTouch Procedure Kit
- Company
- AngioDynamics, Inc.
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-10-17
- Decision date
- 2016-11-16
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified