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FDA 510(k)

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

K-Number: K201446 · 2020-10-01

ApplicantEdwards Lifesiences, LLC
Decision Date2020-10-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module is a medical device manufactured by Edwards Lifesiences, LLC. It received FDA 510(k) clearance on 2020-10-01 under approval number K201446. 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 Monitoring Platform, HemoSphere ClearSight Module?

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module is a medical device that received FDA 510(k) clearance on 2020-10-01. It is manufactured by Edwards Lifesiences, LLC. The 510(k) number is K201446.

When was HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module approved by the FDA?

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module received FDA 510(k) clearance on 2020-10-01, under approval number K201446.

What company makes HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module?

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module is manufactured by Edwards Lifesiences, LLC.

What is the FDA product code for HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module?

The FDA product code for HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module is DQK.

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Related PubMed Literature

PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025)

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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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