đź“‹ FDA Reference
Extroducer Infusion Catheter System
SmartWise Sweden AB
FDA Clearance Information
Pathway
510K
Number
K254051 ↗
Decision Date
September 11, 2026
Product Code
KRA
Device Class
Class 2
Evidence
0 studies
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.