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FDA 510(k)

Swan-Ganz Catheters

K-Number: K193466 · 2020-02-16

ApplicantEdwards Lifesciences, LLC
Decision Date2020-02-16
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 2020-02-16 under approval number K193466. 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 2020-02-16. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K193466.

When was Swan-Ganz Catheters approved by the FDA?

Swan-Ganz Catheters received FDA 510(k) clearance on 2020-02-16, under approval number K193466.

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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