FDA 510(k)

Extroducer Infusion Catheter System

K-Number: K213442 · 2022-06-10

Decision Date2022-06-10

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Extroducer Infusion Catheter System is a medical device manufactured by SmartWise Sweden AB. It received FDA 510(k) clearance on 2022-06-10 under approval number K213442. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extroducer Infusion Catheter System?

Extroducer Infusion Catheter System is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by SmartWise Sweden AB. The 510(k) number is K213442.

When was Extroducer Infusion Catheter System approved by the FDA?

Extroducer Infusion Catheter System received FDA 510(k) clearance on 2022-06-10, under approval number K213442.

What company makes Extroducer Infusion Catheter System?

Extroducer Infusion Catheter System is manufactured by SmartWise Sweden AB.

What is the FDA product code for Extroducer Infusion Catheter System?

The FDA product code for Extroducer Infusion Catheter System is KRA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.