510(k) K233948
K233948 is an FDA 510(k) premarket notification submitted by Provisio Medical, Inc. for the device "Provisio SLT IVUS System". The FDA issued a decision of Substantially Equivalent on April 23, 2024. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2024
- Date Received
- December 14, 2023
- Clearance Type
- Traditional
- 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.