510(k) K253399
K253399 is an FDA 510(k) premarket notification submitted by Volcano Corporation (Dba Philips Image Guided Therapy Device for the device "Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter". The FDA issued a decision of Substantially Equivalent on October 28, 2025. 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
- October 28, 2025
- Date Received
- September 30, 2025
- 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.