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FDA 510(k)

Stratus Infusion Catheter

K-Number: K222185 · 2023-04-13

ApplicantIntervene, Inc.
Decision Date2023-04-13
Product CodeNPG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stratus Infusion Catheter is a medical device manufactured by Intervene, Inc.. It received FDA 510(k) clearance on 2023-04-13 under approval number K222185. The device is classified under product code NPG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stratus Infusion Catheter?

Stratus Infusion Catheter is a medical device that received FDA 510(k) clearance on 2023-04-13. It is manufactured by Intervene, Inc.. The 510(k) number is K222185.

When was Stratus Infusion Catheter approved by the FDA?

Stratus Infusion Catheter received FDA 510(k) clearance on 2023-04-13, under approval number K222185.

What company makes Stratus Infusion Catheter?

Stratus Infusion Catheter is manufactured by Intervene, Inc..

What is the FDA product code for Stratus Infusion Catheter?

The FDA product code for Stratus Infusion Catheter is NPG.

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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.

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