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FDA 510(k)

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

K-Number: K172457 · 2018-06-28

ApplicantDeltex Medical Limited
Decision Date2018-06-28
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is a medical device manufactured by Deltex Medical Limited. It received FDA 510(k) clearance on 2018-06-28 under approval number K172457. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is a medical device that received FDA 510(k) clearance on 2018-06-28. It is manufactured by Deltex Medical Limited. The 510(k) number is K172457.

When was Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM approved by the FDA?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM received FDA 510(k) clearance on 2018-06-28, under approval number K172457.

What company makes Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is manufactured by Deltex Medical Limited.

What is the FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

The FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is DPW.

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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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