510(k) K230584
K230584 is an FDA 510(k) premarket notification submitted by Vein 360, LLC for the device "Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter". The FDA issued a decision of Substantially Equivalent on June 6, 2023. The device falls under product code OWQ (Reprocessed Intravascular Ultrasound Catheter), a Class II device regulated under 21 CFR 870.1200. Vein 360, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2023
- Date Received
- March 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reprocessed Intravascular Ultrasound Catheter
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.