510(k) clearance

Extroducer Infusion Catheter System

FDA 510(k) source

510(k) number

K254051

Applicant

SmartWise Sweden AB

Decision date

Sep 11, 2026

Date received

Dec 17, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KRA

Device type

Catheter, Continuous Flush

Device class

Class II

Regulation

21 CFR 870.1210

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Tullinge, SE