510(k) K123813
K123813 is an FDA 510(k) premarket notification submitted by Vasonova, Inc. for the device "VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE". The FDA issued a decision of Substantially Equivalent on January 18, 2013. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Vasonova, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2013
- Date Received
- December 11, 2012
- 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.