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FDA 510(k)

Swan Ganz Catheters

K-Number: K160084 · 2016-05-03

ApplicantEdwards Lifesciences, LLC
Decision Date2016-05-03
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Swan Ganz Catheters is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-05-03 under approval number K160084. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Swan Ganz Catheters?

Swan Ganz Catheters is a medical device that received FDA 510(k) clearance on 2016-05-03. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K160084.

When was Swan Ganz Catheters approved by the FDA?

Swan Ganz Catheters received FDA 510(k) clearance on 2016-05-03, under approval number K160084.

What company makes Swan Ganz Catheters?

Swan Ganz Catheters is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Swan Ganz Catheters?

The FDA product code for Swan Ganz Catheters is DYG.

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Related Devices (Code: DYG)

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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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