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 a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2017-01-26 under approval 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. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K163693.

When was IntraClude Intra-Aortic Occlusion Device approved by the FDA?

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

What company makes IntraClude Intra-Aortic Occlusion Device?

IntraClude Intra-Aortic Occlusion Device is manufactured by Edwards Lifesciences, LLC.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Edwards Lifesciences, LLC

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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.