510(k) K222679
K222679 is an FDA 510(k) premarket notification submitted by Vascupatent Medical (Shenzhen) Co., Ltd. for the device "Vericor Support Catheter". The FDA issued a decision of Substantially Equivalent on November 7, 2022. 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
- November 7, 2022
- Date Received
- September 6, 2022
- 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