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FDA 510(k)

HemoSphere Advanced Monitor, HemoSphere Pressure Cable

K-Number: K180881 · 2018-11-16

ApplicantEdwards Lifesciences, LLC
Decision Date2018-11-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, HemoSphere Pressure Cable is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2018-11-16 under approval number K180881. 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 HemoSphere Advanced Monitor, HemoSphere Pressure Cable?

HemoSphere Advanced Monitor, HemoSphere Pressure Cable is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K180881.

When was HemoSphere Advanced Monitor, HemoSphere Pressure Cable approved by the FDA?

HemoSphere Advanced Monitor, HemoSphere Pressure Cable received FDA 510(k) clearance on 2018-11-16, under approval number K180881.

What company makes HemoSphere Advanced Monitor, HemoSphere Pressure Cable?

HemoSphere Advanced Monitor, HemoSphere Pressure Cable is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for HemoSphere Advanced Monitor, HemoSphere Pressure Cable?

The FDA product code for HemoSphere Advanced Monitor, HemoSphere Pressure Cable is DQK.

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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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