510(k) K250794
K250794 is an FDA 510(k) premarket notification submitted by Invera Medical for the device "InVera Infusion Device". The FDA issued a decision of Substantially Equivalent on March 12, 2026. 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
- March 12, 2026
- Date Received
- March 14, 2025
- 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