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FDA 510(k)

SMARxT Tubing and Connectors

K-Number: K233702 · 2024-08-08

ApplicantLivaNova USA, Inc.
Decision Date2024-08-08
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARxT Tubing and Connectors is a medical device manufactured by LivaNova USA, Inc.. It received FDA 510(k) clearance on 2024-08-08 under approval number K233702. The device is classified under product code DWE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARxT Tubing and Connectors?

SMARxT Tubing and Connectors is a medical device that received FDA 510(k) clearance on 2024-08-08. It is manufactured by LivaNova USA, Inc.. The 510(k) number is K233702.

When was SMARxT Tubing and Connectors approved by the FDA?

SMARxT Tubing and Connectors received FDA 510(k) clearance on 2024-08-08, under approval number K233702.

What company makes SMARxT Tubing and Connectors?

SMARxT Tubing and Connectors is manufactured by LivaNova USA, Inc..

What is the FDA product code for SMARxT Tubing and Connectors?

The FDA product code for SMARxT Tubing and Connectors is DWE.

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Official Source

View on FDA Database →

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

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