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FDA 510(k)

Edwards Pressure Cable

K-Number: K191089 · 2019-06-13

ApplicantEdwards Lifesciences, LLC
Decision Date2019-06-13
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Edwards Pressure Cable is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-06-13 under approval number K191089. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edwards Pressure Cable?

Edwards Pressure Cable is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K191089.

When was Edwards Pressure Cable approved by the FDA?

Edwards Pressure Cable received FDA 510(k) clearance on 2019-06-13, under approval number K191089.

What company makes Edwards Pressure Cable?

Edwards Pressure Cable is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Edwards Pressure Cable?

The FDA product code for Edwards Pressure Cable is DQK.

Related Clinical Trials

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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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