510(k) K231148
K231148 is an FDA 510(k) premarket notification submitted by Vvt Medical , Ltd. for the device "ScleroSafe 150 mm, ScleroSafe 350 mm". The FDA issued a decision of Substantially Equivalent on June 20, 2023. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2023
- Date Received
- April 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type