510(k) K153094
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 2015
- Date Received
- October 26, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ultrasound, Intravascular
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.