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FDA 510(k)

Xtractor device

K-Number: K211679 · 2022-02-17

ApplicantXcardia Innovation , Ltd.
Decision Date2022-02-17
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Xtractor device is a medical device manufactured by Xcardia Innovation , Ltd.. It received FDA 510(k) clearance on 2022-02-17 under approval number K211679. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xtractor device?

Xtractor device is a medical device that received FDA 510(k) clearance on 2022-02-17. It is manufactured by Xcardia Innovation , Ltd.. The 510(k) number is K211679.

When was Xtractor device approved by the FDA?

Xtractor device received FDA 510(k) clearance on 2022-02-17, under approval number K211679.

What company makes Xtractor device?

Xtractor device is manufactured by Xcardia Innovation , Ltd..

What is the FDA product code for Xtractor device?

The FDA product code for Xtractor device is DRE.

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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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