510(k) K254051
K254051 is an FDA 510(k) premarket notification submitted by SmartWise Sweden AB for the device "Extroducer Infusion Catheter System". The FDA issued a decision of Substantially Equivalent on September 11, 2026. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. SmartWise Sweden AB has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2026
- Date Received
- December 17, 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