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FDA 510(k)

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

K-Number: K183646 · 2019-05-21

ApplicantEdwards Lifeciences, LLC
Decision Date2019-05-21
Product CodeQAQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2019-05-21 under 510(k) number K183646. The device is classified under product code QAQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure?

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is a medical device that received FDA 510(k) clearance on 2019-05-21. The listed applicant is Edwards Lifeciences, LLC. The 510(k) number is K183646.

When did Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure receive FDA 510(k) clearance?

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure received FDA 510(k) clearance on 2019-05-21, under 510(k) number K183646.

Who is the listed applicant for Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure?

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

What is the FDA product code for Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure?

The FDA product code for Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is QAQ.

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.

NCT07510451The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic SurgeryRECRUITINGNCT06871150Three Different GHDT ( Goal Hemodynamic Directed Therapy) Strategies for Intraoperative Fluid Management Optimization During Major Abdominal Surgery: A Randomized Controlled TrialRECRUITINGNCT06729827Predictive Hemodynamic Monitoring During Elective Cesarean SectionCOMPLETEDNCT07070973Proactive Hemodynamic Management During Cytoreductive Surgery and HIPECRECRUITINGNCT07179705Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU PatientsRECRUITINGNCT07288593INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity InterventionNOT_YET_RECRUITING

Other records listing Edwards Lifeciences, 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.

K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableK183413TruWave Disposable Pressure Transducer

Related Devices (Code: QAQ)

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.

K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLCK230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLCK203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC

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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