FDA 510(k)

IntraClude Intra-Aortic Occlusion Device

K-Number: K163693 · 2017-01-26

Decision Date2017-01-26

Product CodeDXC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IntraClude Intra-Aortic Occlusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K163693. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntraClude Intra-Aortic Occlusion Device?

IntraClude Intra-Aortic Occlusion Device is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K163693.

When did IntraClude Intra-Aortic Occlusion Device receive FDA 510(k) clearance?

IntraClude Intra-Aortic Occlusion Device received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163693.

Who is the listed applicant for IntraClude Intra-Aortic Occlusion Device?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntraClude Intra-Aortic Occlusion Device?

The FDA product code for IntraClude Intra-Aortic Occlusion Device is DXC.

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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.