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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 the device name listed in this FDA 510(k) record. The listed applicant is Xcardia Innovation , Ltd.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) 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. The listed applicant is Xcardia Innovation , Ltd.. The 510(k) number is K211679.

When did Xtractor device receive FDA 510(k) clearance?

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

Who is the listed applicant for Xtractor device?

The FDA 510(k) record lists Xcardia Innovation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xtractor device?

The FDA product code for Xtractor device is DRE.

Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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