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FDA 510(k)

The ClearSight finger cuffs

K-Number: K190130 · 2019-06-21

ApplicantEdwards Lifesciences, LLC
Decision Date2019-06-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The ClearSight finger cuffs is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-06-21 under approval number K190130. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The ClearSight finger cuffs?

The ClearSight finger cuffs is a medical device that received FDA 510(k) clearance on 2019-06-21. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K190130.

When was The ClearSight finger cuffs approved by the FDA?

The ClearSight finger cuffs received FDA 510(k) clearance on 2019-06-21, under approval number K190130.

What company makes The ClearSight finger cuffs?

The ClearSight finger cuffs is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for The ClearSight finger cuffs?

The FDA product code for The ClearSight finger cuffs is DXN.

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Other Devices by Edwards Lifesciences, LLC

K161962VAMP Venous/Arterial Blood Management Protection System K160645PreSep Oligon Oximetry Catheter K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform K160084Swan Ganz Catheters K152980Flo Trac sensor, Volume View sensor K172660Duravess bovine pericardial vascular patch

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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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