510(k) K261648
K261648 is an FDA 510(k) premarket notification submitted by Evident Vascular, Inc. for the device "Evident Vascular Guidance System". The FDA issued a decision of Substantially Equivalent on Oct 28, 2026. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 2026
- Date Received
- May 18, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)