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FDA 510(k)

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor

K-Number: K223865 · 2023-06-09

ApplicantEdwards Lifesciences, LLC
Decision Date2023-06-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K223865. 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 ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K223865.

When did HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor receive FDA 510(k) clearance?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor received FDA 510(k) clearance on 2023-06-09, under 510(k) number K223865.

Who is the listed applicant for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor?

The FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor is DQK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05083403HPI (Hypotension Prediction Index) Care TrialTERMINATEDNCT06871150Three Different GHDT ( Goal Hemodynamic Directed Therapy) Strategies for Intraoperative Fluid Management Optimization During Major Abdominal Surgery: A Randomized Controlled TrialRECRUITINGNCT07510451The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic SurgeryRECRUITINGNCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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