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The Tracker / September 2026 / K254051

510(k) cleared

Extroducer Infusion Catheter System

SmartWise Sweden AB · Sep 11, 2026 · K254051

FDA cleared the Extroducer Infusion Catheter System from SmartWise Sweden AB on Sep 11, 2026 under K254051, a traditional 510(k). The device falls under product code KRA, Catheter, Continuous Flush, regulated at 21 CFR 870.1210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 17, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for SmartWise Sweden AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254051?

K254051 is the FDA 510(k) for Extroducer Infusion Catheter System, submitted by SmartWise Sweden AB. FDA's decision date was Sep 11, 2026, under product code KRA (Catheter, Continuous Flush).

Who makes the Extroducer Infusion Catheter System?

SmartWise Sweden AB, based in Tullinge, is the applicant of record for K254051.

How long did the K254051 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Sep 11, 2026, 268 days later.

← All decisions in September 2026